practice
Do ready-made compression stockings fit the anatomy of the venous leg ulcer patient? Objective: How usable two standardised measuring methods are for the selection of three different brands of ready-made below-knee compression stockings. Furthermore, this study aims to determine how many of the included patients fit into a ready-made compression stocking in a limited selection of brands. l Method: Consecutive patients suffering from venous insufficiency and treated at a specialised wound healing centre were included in this prospective comparative study. Two standardised measuring methods were used to evaluate the suitability of three different brands of ready-made below knee compression stockings. The circumference was measured at three points and seven points below the knee. The results of these measurements were compared to three selected brands of ready-made compression stockings. l Results: Together, 43 consecutive patients (25 men and 18 women) were included in the study. When the leg was measured at three points, 53.5%, 34.9% and 0% of the patients fitted into brand 1, brand 2 and brand 3 of the ready-made compression stockings, respectively. When measured at seven points, only 4.7% of the patients fitted into brand 1, 7% in brand 2 and 0% of the patients fitted into brand 3. l Conclusion: These results demonstrate that there is a need to standardise measuring methods in the selection of ready-made below-knee compression stockings and a need for an evaluation of the present stocking sizes in relation to the anatomy of the venous leg ulcer patient. This study has shown that ready-made compression stockings presently prescribed will not properly fit the majority of patients to prevent oedema and ulcer recurrence. Further studies focused on the development of new sizes or changes in fitting recommendations may help solve these problems. l Declaration of interest: There were no external sources of funding for this study. The authors have no conflicts of interest to declare with regard to the manuscript or its content. l
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T
he non-healing wound is defined as a wound that is resistant to therapy and becomes chronic, providing a healthcare risk for patients and reducing their quality of life.1 Non-healing wounds have a multifactorial etiology, and leg ulcers represent a significant proportion of these chronic wounds. Of all leg ulcers, 80–85% is caused by venous insufficiency due to venous hypertension in the lower extremities. Venous insufficiency is a chronic condition, which can lead to skin changes, oedema and venous ulceration, an often very painful condition.2 Patients suffering from venous leg ulceration are at risk of getting infections, leading to repeat dosing with antibiotics and in many cases, hospitalisation.3 Compression therapy is the golden standard for the treatment of venous leg ulceration, supported by the latest Cochrane review,4 where the authors concluded that “compression increases ulcer healing rates compared with no compression”. Compression therapy works through improving venous pump function, reducing venous reflux, accelerating venous flow and redistributing blood to the central section of the body.5 However, venous leg ulceration
is a chronic recurrent condition, and in spite of an increased healing rate in the past years, there remains an increasing number of patients who are at risk for recurrent venous ulcers.6 Studies have documented a 12-month recurrence rate of 26–39% for patients after treatment with compression stockings class I– III.6,7 One of the most frequently mentioned reasons for recurrence is the patient’s non-concordance to compression therapy. Non-concordance to compression therapy is directly linked to increased risk of recurrence. It has been documented that the physical appearance of the stockings and the belief that are uncomfortable to wear influences the outcomes of the treatment.8,9 The evidence to support compression as prophylaxis, using compression stockings, is nevertheless not robust,10 and the extent of the prophylactic effect is still uncertain. This may be based on problems in choosing the optimal type of compression stockings in regard to pressure, stiffness, length and knitting type, but also how the stockings are used. Compression stockings are produced in standard sizes, so called ‘ready-made’ compression stockings. Some manufacturers also provide compression
© 2014 MA Healthcare
S. Nørregaard,1 RN, DH; S. Bermark,1 RN, DH; F. Gottrup,1 MD, DMSci, Professor of Surgery; 1 The Copenhagen Wound Healing Center, Copenhagen, Denmark. Email: susan.norregaard@ regionh.dk
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venous leg ulcer ; compression; ready-made compression stockings; measuring methods
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Inclusion criteria
Exclusion criteria
• Patients with venous insufficiency • Patients treated with compression bandages in the center • Patients assessed to be treated with compression stockings • Patients with ankle brachial pressure index (ABPI) > 0.8 and 18 years • Patients who can understand Danish • Patients who gave oral informed consent
• Patients not diagnosed with venous insufficiency • Patients with ABPI 1.3 mmHg • Patients who do not understand Danish • Patients with dementia • Patients clinical evaluated to have oedema
Method Study design The study design is a prospective, consecutive, comparative study of two standardised methods to select the right size of a ready-made, below-knee compression stocking. Patients enrolled in the study were all treated by specialised physicians and wound care nurses at the CWHC. Inclusion and exclusion criteria are shown in Table 1. All patients had been treated for venous leg ulcerations and had received standard treatment with compression bandages prior to study enrolment. The patient’s wounds were deemed to be completely healed, or to be so small and shallow that they will heal within one week. Given this, the wound size was not measured. The patients were clinically assessed by a specialised physician, who prescribed a change from compression bandaging to below-knee compression stockings. The measurement protocol used in this study
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Table 1 Inclusion and exclusion criteria
CWHC has experienced a range of different problems in treatment with compression stockings. In the outpatient clinic, patients with slippage of the stockings, pressure marks and even pressure ulcers as a result of compression stockings are seen regularly. Furthermore, many patients present with recurrent oedema and venous leg ulceration. The background for these problems may stem from the lack of a national standard and evidence of the efficacy of the different types, brands and lengths of compression stockings. However, the lack of concordance to compression therapy may also influence the result. Most venous leg ulcer patients at the CWHC are prescribed knee-high class II compression stockings, and the majority is treated with ready-made compression stockings. However, the measurements and brand selection is not performed at the centre, but is executed by the local authorities. For this reason, the CWHC is not involved, and is not aware of how the actual measurement, and the selection of the type, size and brand of stockings are conducted. This raises two essential questions; firstly, does the measuring method influence the selection of ready-made below-knee compression stockings to a group of patients with venous leg ulcers? Furthermore, do 80% of patients really fit into ready-made compression stockings, as previously reported?14 The aim of this study therefore is to determine whether the two measuring methods used are appropriate in deciding the right choice of size, in a limited selection of ready-made below-knee compression stockings to a group of patients with venous leg ulcers treated at the CWHC. This study additionally strives to elucidate how many of the included patients fit into the ready-made compression stockings manufactured by 3 different companies.
© 2014 MA Healthcare
stockings that are custom-made, however not all companies and brands provide this service. Compression stockings require prescription by a physician. Different types, classes and lengths of compression stockings are currently available on the market, but the evidence to support the efficacy of different brands, class and length of the stockings remain inadequate.10 Germany and the UK have developed a national standard for prescribing compression stockings, using the pressure applied by the stockings to categorise them into four different categories. However, the pressure range in the four classes varies between the different national standards.11 Several attempts to create a European standard have been made, but have so far failed and hence the optimal therapeutic pressure and the correlation between the pressure applied and static stiffness are still under investigation.12,13 In Denmark, local authorities reimburse the cost of compression stockings. Companies on contract with local authorities administer the measurements, choice of size and the brands. Arpaia et al. have suggested that 80% of all patients should, in theory, fit into a ready-made below-knee compression stocking.14 This figure has been used in Denmark in contracts between companies and local authorities (municipals). These contracts contain specifications and requirements focusing on a small selection of brands of ready-made compression stockings. In general, there are no performance specifications in the contracts regarding classification, no guidance on measurement and no demands of education to the companies. In Denmark, a national standard for the classification of compression stockings is non-existent, similar to many other countries. The Copenhagen Wound Healing Centre (CWHC) is a multidisciplinary centre that treats patients with all types of problem wounds.1 At the outpatient clinic, 12000 consultations take place every year, and approximately 53% of these patients suffer from leg ulcers, predominantly caused by deep venous insufficiency. The standard treatment for these patients is compression therapy, and the
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practice was designed to mimic the method used by the Danish local authorities. We used a three point measuring method as recommended on the packaging of the ready-made compression stockings. A seven point measuring method was chosen as the second method of assessment. These measurement methods are available in all measuring charts from companies who manufacture ready-made compression stockings.
Fig 1. Schematic description of the three and seven point measuring method
Measurement method • Three point measurement: circumference measurements at point B and D of the leg and the length of the leg from heel to the hollow of the knee AD (Fig 1) • Seven point measurement: circumference measurements at point A, Y, B, B1, C, D of the leg and the length of the leg from the heel to the hollow of the knee AD (Fig 1). When the decision was made by the physician, following clinical assessment to change treatment to compression stockings, the measurements were immediately performed. All measurements were conducted by the same clinician using a tape measure, and recorded into a database.
Compression stocking brands The brands selected in this study were the most commonly used compression stockings prescribed to patients by local authorities in the Copenhagen area. The brands chosen were Sigvaris® (Brand A), Egertina Goslar® (Brand B) and Veno Elegance® (Brand C; Table 2–4).The number of sizes from each brand was identified. Brand A had 9 different sizes that were available in short and long lengths, totalling 18 different products (Table 2). Brand B had 5 different sizes that were available in short, normal and long length, totalling 15 different products (Table 3) and brand C had 6 different sizes that were available in short and long length, totalling 12 different products (Table 4). The range in circumference and lengths, in comparable levels, was not similar between the three brands. For each brand, the measurements from
method 1 and 2 were compared to the standard size chart, to determine how many of the patients could fit into one size, at three and seven measuring points. The performed measurements, the sizes from the three brands and the patient characteristics were entered into a database. It was defined that the patients could fit into one of the sizes in each brand, if all three and all seven measuring points fitted into one size in the size-charts of the three brands.
Statistical analyses A professional statistician performed the analysis of the results. Baseline demographic and disease characteristics are summarised for the full cohort of patients. Means and SDs were calculated for continuous variables (age, body mass index, height, ABPI and ulcer duration). Frequencies and percentages were generated for categorical outcomes (gender, diabetes, legs position etc.). All patients included in the study (intention to-treat/ITT population)
Table 2. Brand 1 Sigvaris 500 X-small
Small
Small Plus
Medium
Medium Plus
Large
Large Plus
X-large
X-large plus
D
26–32
28–34
32–38
31–37
36–42
34–40
40–46
38–43
44–49
C
28–31
31–36
35–40
34–39
39–44
37–42
43–48
40–45
47–52
B1
21–24
24–29
24–29
29–32
29–32
32–36
32–36
35–39
35–39
B
17–19
19–23
19–23
23–26
23–26
26–29
26–29
29–32
29–32
Y
25–28
28–32
28–32
32–35
32–35
35–38
35–38
38–41
39–41
A
17–18
19–23
19–23
23–26
23–26
26–29
26–29
29–32
29–32
ℓ A-D short 33–37 cm, and ℓ A-D long 38–44cm
s
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Size chart with circumference ranges at all measurement points and sizes (cm)
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practice
II
III
IV
V
VI
D
32–36
34–38
36–40
37–41
39–43
C
33–37
35–39
37–41
38–42
40–45
B1
26–29
28–31
30–34
32–36
34–38
B
20–23
22–25
24–27
26–29
28–31
Y
29–32
31–35
33–37
35–39
36–40
A
20–23
22–25
24–27
26–29
28–31
ℓ A-D short 34-37 cm and ℓ A-D normal. 37–40cm and ℓ A-D long 40–43cm
Table 4. Brand 3 Veno Eleance Size chart with circumference ranges at all measurement points and sizes (cm) I
II
III
IV
V
VI
D
28
29.5–31
32.5–34
35.5–37
38.5–40
41.5–43
C
30
31.5–33
34.5–36
37.5–39
40.5–42
43.5–45
B1
24
25.5–26.5
27.5–29
30–31.5
32.5–34
35–36.5
B
19
20–21
22–23
24–25
26–27
28–29
Y
28
29–30
31–32
33–34
35–36
37–38
A
19
20–21
22–23
24–25
26–27
28–29
ℓ A-D short 35–36 cm and ℓ A-D long 37–39 cm
Results In total, 43 patients, 25 men and 18 women with venous insufficiency were included in this study (Table 5). The patients in this study had above average height and BMI. The ulcers have been present for several years (mean=6.7 years). In table 6 and 7, the data of how many measuring points and patients that fit into one size within range, out of 3 and 7, in each brand are shown. The statistic of each measuring point is shown in Table 8. Comparing our measurements with the size charts from the three brands, we found that the number of patients who could fit into one of the standard sizes were as follows: • Brand A: Using the three point measuring method (Table 9), 53.5% of the patients in this study could fit into one of the sizes in this brand, but only 4.7% of patients could when using the seven point measuring method • Brand B: Using the three point measuring method, 34.9%, of the patients in this study could fit into one of the sizes in this brand, but only 7.0% of patients could when using the seven point measuring method • Brand C: Using the three point and the seven point measuring method, 0% of the patients in this study could fit into one of the sizes in this brand.
Table 5. Patient characteristics
Discussion
Male / Female
male n=25, female n=18
Age
Range 38–93 years, median 63.5 years (mean 63.26).
BMI
Between 18 and 59, median 28 (mean 29.95)
Height
Mean 175cm (SD 11.37)
Diabetes
5 of 43 patients had type 2 diabetes
ABPI
Mean 1.08 (SD 0.144)
Leg ulcer
30 of 43 patients had leg ulcers not yet completely healed
Legs – position
Right leg 22, left leg 21
Ulcer duration (n=28)
Mean 6,7 years (SD 10.49)
Duplex scan performed
29 out of the 43 patients
Compression therapy is the main treatment for venous leg ulceration. Compression bandages are used for oedema reduction and leg ulcer healing, while compression stockings are mainly are used as a preventative measure against the recurrence of oedema and venous leg ulceration.15 This study was performed in light of all the complications and lack of efficacy observed with the current treatment with compression stockings. In a survey involving physicians (n=154) in general surgery in Scotland, 32% (n=49) reported at least one case of damage induced by compression.16 According to Arpaia et al., 80% of all patients should, in theory, fit into a ready-made below-knee compression stockings.14 The local authorities in Denmark have estimated that 80% of the patients who require treatment with compression stockings (lymphedema patients included) can fit into readymade compression stockings. These stockings can only prevent and remove oedema within the range of the size of the brand given to the patient and therefore the actual measurement of the compression stocking are performed when the patient is free of oedema. However, in Denmark we have no standard criteria for the clinical assessment of oedema of
Table 6. Number of patients and how many measuring points within range of one size, out of three, in each brand Number of measuring point fitting into the different brands
Brand A n= 43
Brand B n=43
Brand C n=43
3
23
15
0
2
19
18
9
1
1
9
28
0
0
1
6
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Size chart with circumference ranges at all measurement points and sizes (cm)
were also included in final analyses (per-protocol/PP population). The data were collected over 4 weeks, and were analysed using SPSS, version 13.
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Table 3. Brand 2 Egertina Goslar
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Number of measuring point fitting into the different brands
Brand A n=43
Brand B n=43
Brand C n=43
7
2
3
0
6
7
4
0
5
13
13
0
4
17
9
3
3
4
13
11
2
0
1
21
1
0
0
8
Table 8. Statistics of each measuring point Standard Circumference Measurments (cm)
Median n=43
Minimum –Maximum n=43
10 percentile n=43
90 percentile n=43
cA
24.0
21.0 – 38.0
21.7
27.0
cY
34.0
28.0 – 41.5
31.0
38.8
cB
23.0
17.0 – 32.0
19.4
27.6
cB1
24.0
19.5 – 39.0
22.5
35.6
cC
35.0
26.0 – 51.0
29.1
46.3
cD
37.0
29.0 – 51.0
31.7
48.0
A-D
42.0
34.0 – 50.0
35.4
47.0
Table 9.The allocation of patients, illustrated in percentages, that fits the three brands using the 3 and 7 point measuring method. Brand A (9 sizes in 2 length)
Brand B (5 sizes in 3 length)
Brand C (6 sizes in 2 length)
3 point measurements
53.5 %
34.9%
0%
7 point measurements
4.7%
7.0%
0%
the lower legs. Therefore the assessment of when the patient’s legs are free of oedema is purely an individual clinical decision, made by different health care professionals. In this study, all patients were clinical assessed by the same experienced physicians and the same wound care nurse performed the measurements. In this study, the three and the seven point measurement protocol, was employed; however, why two different measuring methods exist is not clear. There are furthermore no guidelines to when, where, who and how the two different methods are to be used and if one method is preferred to the other. This decision, therefore, is completely based on the experience and knowledge of the person performing the measurements. There is a huge discrepancy in our results between the two measuring methods. This discrepancy suggests that the two measuring methods are not suited to select ready134
made compression stocking and furthermore ready-made compression stockings are not suited to be used in patients suffering from venous leg ulcers. The measuring method used to select the most accurate size of ready-made compression stockings may therefore play an important role in the rate of recurrence. Our results are comparable to a clinical questionnaire study from Italy.14 This study reported that only between 16–50% of the patients treated for venous leg ulceration could benefit from the treatment with ready-made compression stockings. The problem may be that ready made compression stockings are produced in standard sizes with a minimum and maximum circumference range and length, at internationally agreed measuring points, but based on an average of measurements in healthy volunteers, and not in venous leg ulcer patients.11,12 Another problem may be that the range of sizes may differ between companies and brands. In total, only 29 patients in this study were confirmed to exhibit venous leg ulceration by duplex scan and the remainder of the patients were diagnosed clinically, where ischemia was excluded. A mean value of 6.7 years for ulcer duration confirmed that the group of patients in this study all exhibited hard-to-heal venous leg ulcers. Shiman et al.17 described chronic venous insufficiency as a complex disease with venous ulceration, neuropathy, affected mobility and range of motion and gate abnormalities, which affects the calf muscle function. In addition, Yang et al.18 found a significant impairment of calf muscle function in patients with chronic venous insufficiency, compared with healthy control subjects. Venous hypertension and venous leg ulcers can cause leg muscle atrophy, and about half of the patients who have been treated for a venous leg ulcer can have changes in leg proportion. This results in a situation where the venous leg ulcer patients with severe changes in calf muscle and leg proportions are treated with ready-made compression stockings in sizes manufactured to fit only healthy individuals.12 This may offer a possible explanation for the discrepancy in our results between the two measuring methods, and the low amount of patients that could fit into ready-made compression stockings in our study. The other important issue is how the measurements for selection of ready-made below-knee compression stockings below knee are performed. Accurate measurements are important to ensure that the chosen type of compression stocking fits well and is comfortable to wear, in order to promote good compliance.15 If the stockings do not properly fit due to inaccurate measurements, it will result in discomfort for the patient, potential trauma, further ulceration and a waste of resources.18 This raises several questions:
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Table 7. Number of patients and how many measuring points within range of one size, out of 7, in each brand.
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practice Conclusion
• Firstly, is it possible to make ready-made belowknee compressions stockings which will fit a significant number of venous leg ulcer patients, or will each patient need to have a tailor-made stocking? • Would ready-made below-knee stockings better fit the patients if the compression stockings are manufactured in sizes based on venous leg ulcer patients? • Finally, what is the most simple but adequate measuring method available for selecting readymade stockings below knee? Is a measuring method with only 2 circumference measurements adequate or is more circumference measurements needed? Also where are the most optimal anatomical places to measure? Future studies are needed to answer these questions and to improve the outcome of using ready-made below knee compression stockings.
The results of this study show that using the three point measuring method for selection of ready- made compression stockings only fits at most 53.5% of patients and not 80% of the venous leg ulcer patients, as previously proposed.14 Using the seven point measuring method, the comparable figures was 0%–4.7%. There is a need for standardised measuring methods in the selection of ready-made compression stockings and a need for an evaluation of the present sizes in compression stockings, in relation to the anatomy of the venous leg ulcer patient. At present, these stockings will not properly fit and be effective in preventing oedema and ulcer recurrence in the majority of patients. Further studies focused on standardising sizes or the implementation of changes in fitting recommendations may help in preventing ulcer recurrence in patients. n
References 1 Gottrup, F., Holstein, P., Jørgensen, B., et al. A new concept of a multidisciplinary wound healing center and a national expert function of wound healing. Arch Surg 2001; 136: 7, 765–772. 2 Trent, J.T., Falabella, A., Eaglstein, W.H., Kirsner, R.S.Venous ulcers: pathophysiology treatment options. Ostomy wound manage 2005; 51: 5, 38–54. 3 Simon, D.A., Dix, F.P., McCollum, C.N. Management of venous leg ulcers. BMJ 2004; 328: 7452, 1358–1362. 4 O`Meara, S., Cullum, N.A., Nelson, E.A. Compression for venous leg ulcers. Cochrane Database Syst Rev 2009; 21: 1, CD000265. 5 Moffatt, C. Compression therapy in practice. Wounds UK, Aberdeen, 2007. 6 Nelson, E.A., Bell-Syer, S.E.
10 Nelson, E.A., Harper, D.R., Prescott, R.J., et al. Prevention of recurrence of venous ulceration: Randomized controlled trial class 2 and 3 elastic compression. J Vasc Surg 2006; 44: 4, 803–808. 11 Lymphoedema Framework: Template for Practice: compression hosiery in lymphoedema. London: MEP Ltd, 2006. 12 Partsch, H., Rabe, E., Stemmer, R. Compression therapy of the extremities. Paris: Editions Phlebologiques Francaises, 1999. 13 Wong, I.K., Man, M.B., Chan, O.S., et al. Comparison of the interface pressure and stiffness of four types of compression systems. J Wound Care 2012; 21: 4, 161–167. 14 Arpaia, G., Milani, M., Addeo, R. et al. Clinical validation of a specially sized class ll compression knee-sock for the prevention of recurrent ulcers in
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patients with chronic venous stasis. Int Angiol 2008; 27: 6, 507–511. 15 Williams, C. Leg ulcer after care: the role of compression hosiery. Br J Nurs 2000; 9: 13, 822–828. 16 Callam, M.J., Ruckley, C.V., Dale, J.J., Harpe, D.R. Hazards of compression treatment of the leg: an estimate from Scottish surgeons. Br Med J 1987; 28: 295, 6610, 1382. 17 Shiman, M.I., Pieper, B., Templin, T.N., et al. A reappraisal analyzing the effects of neuropathy, muscle involvement, and range of motion upon gait and calf muscle function. Wound Repair Regen 2009; 17: 2, 147–152. 18 Yang, D.,Vandongen,Y.K., Stacey, M.C. Changes in calf muscle function in chronic venous disease. Cardiovasc Surg 1999; 7: 4, 451–456.
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Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev 2012; 15: 8, CD002303. 7 Clarke-Moloney, M., Keane, N., O’Connor,V., et al. Randomized controlled trial comparing European standard class 1 to class 2 compression stockings for ulcer recurrence and patient compliance. Int Wound J 2012; 19 [Epub ahead of print]. 8 Moffatt Christine, Kommala Dheerendra, Choe Yoonhee. Venous leg ulcers: Patient concordance with compression therapy and its impact on healing and prevention of recurrence. Int Wound J 2009;6:386-393 9 Jull, A.B., Mitchell, N., Arroll, J., et al. Factors influencing concordance with compression stockings after venous leg ulcer healing. J Wound Care 2004; 13: 3, 90–92.
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Do ready-made compression stockings fit the anatomy of the venous leg ulcer patient? Objective: How usable two standardised measuring methods are for the selection of three different brands of ready-made below-knee compression stockings. Furthermore, this study aims to determine how many of the included patients fit into a ready-made compression stocking in a limited selection of brands. l Method: Consecutive patients suffering from venous insufficiency and treated at a specialised wound healing centre were included in this prospective comparative study. Two standardised measuring methods were used to evaluate the suitability of three different brands of ready-made below knee compression stockings. The circumference was measured at three points and seven points below the knee. The results of these measurements were compared to three selected brands of ready-made compression stockings. l Results: Together, 43 consecutive patients (25 men and 18 women) were included in the study. When the leg was measured at three points, 53.5%, 34.9% and 0% of the patients fitted into brand 1, brand 2 and brand 3 of the ready-made compression stockings, respectively. When measured at seven points, only 4.7% of the patients fitted into brand 1, 7% in brand 2 and 0% of the patients fitted into brand 3. l Conclusion: These results demonstrate that there is a need to standardise measuring methods in the selection of ready-made below-knee compression stockings and a need for an evaluation of the present stocking sizes in relation to the anatomy of the venous leg ulcer patient. This study has shown that ready-made compression stockings presently prescribed will not properly fit the majority of patients to prevent oedema and ulcer recurrence. Further studies focused on the development of new sizes or changes in fitting recommendations may help solve these problems. l Declaration of interest: There were no external sources of funding for this study. The authors have no conflicts of interest to declare with regard to the manuscript or its content. l
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T
he non-healing wound is defined as a wound that is resistant to therapy and becomes chronic, providing a healthcare risk for patients and reducing their quality of life.1 Non-healing wounds have a multifactorial etiology, and leg ulcers represent a significant proportion of these chronic wounds. Of all leg ulcers, 80–85% is caused by venous insufficiency due to venous hypertension in the lower extremities. Venous insufficiency is a chronic condition, which can lead to skin changes, oedema and venous ulceration, an often very painful condition.2 Patients suffering from venous leg ulceration are at risk of getting infections, leading to repeat dosing with antibiotics and in many cases, hospitalisation.3 Compression therapy is the golden standard for the treatment of venous leg ulceration, supported by the latest Cochrane review,4 where the authors concluded that “compression increases ulcer healing rates compared with no compression”. Compression therapy works through improving venous pump function, reducing venous reflux, accelerating venous flow and redistributing blood to the central section of the body.5 However, venous leg ulceration
is a chronic recurrent condition, and in spite of an increased healing rate in the past years, there remains an increasing number of patients who are at risk for recurrent venous ulcers.6 Studies have documented a 12-month recurrence rate of 26–39% for patients after treatment with compression stockings class I– III.6,7 One of the most frequently mentioned reasons for recurrence is the patient’s non-concordance to compression therapy. Non-concordance to compression therapy is directly linked to increased risk of recurrence. It has been documented that the physical appearance of the stockings and the belief that are uncomfortable to wear influences the outcomes of the treatment.8,9 The evidence to support compression as prophylaxis, using compression stockings, is nevertheless not robust,10 and the extent of the prophylactic effect is still uncertain. This may be based on problems in choosing the optimal type of compression stockings in regard to pressure, stiffness, length and knitting type, but also how the stockings are used. Compression stockings are produced in standard sizes, so called ‘ready-made’ compression stockings. Some manufacturers also provide compression
© 2014 MA Healthcare
S. Nørregaard,1 RN, DH; S. Bermark,1 RN, DH; F. Gottrup,1 MD, DMSci, Professor of Surgery; 1 The Copenhagen Wound Healing Center, Copenhagen, Denmark. Email: susan.norregaard@ regionh.dk
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venous leg ulcer ; compression; ready-made compression stockings; measuring methods
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Inclusion criteria
Exclusion criteria
• Patients with venous insufficiency • Patients treated with compression bandages in the center • Patients assessed to be treated with compression stockings • Patients with ankle brachial pressure index (ABPI) > 0.8 and 18 years • Patients who can understand Danish • Patients who gave oral informed consent
• Patients not diagnosed with venous insufficiency • Patients with ABPI 1.3 mmHg • Patients who do not understand Danish • Patients with dementia • Patients clinical evaluated to have oedema
Method Study design The study design is a prospective, consecutive, comparative study of two standardised methods to select the right size of a ready-made, below-knee compression stocking. Patients enrolled in the study were all treated by specialised physicians and wound care nurses at the CWHC. Inclusion and exclusion criteria are shown in Table 1. All patients had been treated for venous leg ulcerations and had received standard treatment with compression bandages prior to study enrolment. The patient’s wounds were deemed to be completely healed, or to be so small and shallow that they will heal within one week. Given this, the wound size was not measured. The patients were clinically assessed by a specialised physician, who prescribed a change from compression bandaging to below-knee compression stockings. The measurement protocol used in this study
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Table 1 Inclusion and exclusion criteria
CWHC has experienced a range of different problems in treatment with compression stockings. In the outpatient clinic, patients with slippage of the stockings, pressure marks and even pressure ulcers as a result of compression stockings are seen regularly. Furthermore, many patients present with recurrent oedema and venous leg ulceration. The background for these problems may stem from the lack of a national standard and evidence of the efficacy of the different types, brands and lengths of compression stockings. However, the lack of concordance to compression therapy may also influence the result. Most venous leg ulcer patients at the CWHC are prescribed knee-high class II compression stockings, and the majority is treated with ready-made compression stockings. However, the measurements and brand selection is not performed at the centre, but is executed by the local authorities. For this reason, the CWHC is not involved, and is not aware of how the actual measurement, and the selection of the type, size and brand of stockings are conducted. This raises two essential questions; firstly, does the measuring method influence the selection of ready-made below-knee compression stockings to a group of patients with venous leg ulcers? Furthermore, do 80% of patients really fit into ready-made compression stockings, as previously reported?14 The aim of this study therefore is to determine whether the two measuring methods used are appropriate in deciding the right choice of size, in a limited selection of ready-made below-knee compression stockings to a group of patients with venous leg ulcers treated at the CWHC. This study additionally strives to elucidate how many of the included patients fit into the ready-made compression stockings manufactured by 3 different companies.
© 2014 MA Healthcare
stockings that are custom-made, however not all companies and brands provide this service. Compression stockings require prescription by a physician. Different types, classes and lengths of compression stockings are currently available on the market, but the evidence to support the efficacy of different brands, class and length of the stockings remain inadequate.10 Germany and the UK have developed a national standard for prescribing compression stockings, using the pressure applied by the stockings to categorise them into four different categories. However, the pressure range in the four classes varies between the different national standards.11 Several attempts to create a European standard have been made, but have so far failed and hence the optimal therapeutic pressure and the correlation between the pressure applied and static stiffness are still under investigation.12,13 In Denmark, local authorities reimburse the cost of compression stockings. Companies on contract with local authorities administer the measurements, choice of size and the brands. Arpaia et al. have suggested that 80% of all patients should, in theory, fit into a ready-made below-knee compression stocking.14 This figure has been used in Denmark in contracts between companies and local authorities (municipals). These contracts contain specifications and requirements focusing on a small selection of brands of ready-made compression stockings. In general, there are no performance specifications in the contracts regarding classification, no guidance on measurement and no demands of education to the companies. In Denmark, a national standard for the classification of compression stockings is non-existent, similar to many other countries. The Copenhagen Wound Healing Centre (CWHC) is a multidisciplinary centre that treats patients with all types of problem wounds.1 At the outpatient clinic, 12000 consultations take place every year, and approximately 53% of these patients suffer from leg ulcers, predominantly caused by deep venous insufficiency. The standard treatment for these patients is compression therapy, and the
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practice was designed to mimic the method used by the Danish local authorities. We used a three point measuring method as recommended on the packaging of the ready-made compression stockings. A seven point measuring method was chosen as the second method of assessment. These measurement methods are available in all measuring charts from companies who manufacture ready-made compression stockings.
Fig 1. Schematic description of the three and seven point measuring method
Measurement method • Three point measurement: circumference measurements at point B and D of the leg and the length of the leg from heel to the hollow of the knee AD (Fig 1) • Seven point measurement: circumference measurements at point A, Y, B, B1, C, D of the leg and the length of the leg from the heel to the hollow of the knee AD (Fig 1). When the decision was made by the physician, following clinical assessment to change treatment to compression stockings, the measurements were immediately performed. All measurements were conducted by the same clinician using a tape measure, and recorded into a database.
Compression stocking brands The brands selected in this study were the most commonly used compression stockings prescribed to patients by local authorities in the Copenhagen area. The brands chosen were Sigvaris® (Brand A), Egertina Goslar® (Brand B) and Veno Elegance® (Brand C; Table 2–4).The number of sizes from each brand was identified. Brand A had 9 different sizes that were available in short and long lengths, totalling 18 different products (Table 2). Brand B had 5 different sizes that were available in short, normal and long length, totalling 15 different products (Table 3) and brand C had 6 different sizes that were available in short and long length, totalling 12 different products (Table 4). The range in circumference and lengths, in comparable levels, was not similar between the three brands. For each brand, the measurements from
method 1 and 2 were compared to the standard size chart, to determine how many of the patients could fit into one size, at three and seven measuring points. The performed measurements, the sizes from the three brands and the patient characteristics were entered into a database. It was defined that the patients could fit into one of the sizes in each brand, if all three and all seven measuring points fitted into one size in the size-charts of the three brands.
Statistical analyses A professional statistician performed the analysis of the results. Baseline demographic and disease characteristics are summarised for the full cohort of patients. Means and SDs were calculated for continuous variables (age, body mass index, height, ABPI and ulcer duration). Frequencies and percentages were generated for categorical outcomes (gender, diabetes, legs position etc.). All patients included in the study (intention to-treat/ITT population)
Table 2. Brand 1 Sigvaris 500 X-small
Small
Small Plus
Medium
Medium Plus
Large
Large Plus
X-large
X-large plus
D
26–32
28–34
32–38
31–37
36–42
34–40
40–46
38–43
44–49
C
28–31
31–36
35–40
34–39
39–44
37–42
43–48
40–45
47–52
B1
21–24
24–29
24–29
29–32
29–32
32–36
32–36
35–39
35–39
B
17–19
19–23
19–23
23–26
23–26
26–29
26–29
29–32
29–32
Y
25–28
28–32
28–32
32–35
32–35
35–38
35–38
38–41
39–41
A
17–18
19–23
19–23
23–26
23–26
26–29
26–29
29–32
29–32
ℓ A-D short 33–37 cm, and ℓ A-D long 38–44cm
s
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Size chart with circumference ranges at all measurement points and sizes (cm)
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practice
II
III
IV
V
VI
D
32–36
34–38
36–40
37–41
39–43
C
33–37
35–39
37–41
38–42
40–45
B1
26–29
28–31
30–34
32–36
34–38
B
20–23
22–25
24–27
26–29
28–31
Y
29–32
31–35
33–37
35–39
36–40
A
20–23
22–25
24–27
26–29
28–31
ℓ A-D short 34-37 cm and ℓ A-D normal. 37–40cm and ℓ A-D long 40–43cm
Table 4. Brand 3 Veno Eleance Size chart with circumference ranges at all measurement points and sizes (cm) I
II
III
IV
V
VI
D
28
29.5–31
32.5–34
35.5–37
38.5–40
41.5–43
C
30
31.5–33
34.5–36
37.5–39
40.5–42
43.5–45
B1
24
25.5–26.5
27.5–29
30–31.5
32.5–34
35–36.5
B
19
20–21
22–23
24–25
26–27
28–29
Y
28
29–30
31–32
33–34
35–36
37–38
A
19
20–21
22–23
24–25
26–27
28–29
ℓ A-D short 35–36 cm and ℓ A-D long 37–39 cm
Results In total, 43 patients, 25 men and 18 women with venous insufficiency were included in this study (Table 5). The patients in this study had above average height and BMI. The ulcers have been present for several years (mean=6.7 years). In table 6 and 7, the data of how many measuring points and patients that fit into one size within range, out of 3 and 7, in each brand are shown. The statistic of each measuring point is shown in Table 8. Comparing our measurements with the size charts from the three brands, we found that the number of patients who could fit into one of the standard sizes were as follows: • Brand A: Using the three point measuring method (Table 9), 53.5% of the patients in this study could fit into one of the sizes in this brand, but only 4.7% of patients could when using the seven point measuring method • Brand B: Using the three point measuring method, 34.9%, of the patients in this study could fit into one of the sizes in this brand, but only 7.0% of patients could when using the seven point measuring method • Brand C: Using the three point and the seven point measuring method, 0% of the patients in this study could fit into one of the sizes in this brand.
Table 5. Patient characteristics
Discussion
Male / Female
male n=25, female n=18
Age
Range 38–93 years, median 63.5 years (mean 63.26).
BMI
Between 18 and 59, median 28 (mean 29.95)
Height
Mean 175cm (SD 11.37)
Diabetes
5 of 43 patients had type 2 diabetes
ABPI
Mean 1.08 (SD 0.144)
Leg ulcer
30 of 43 patients had leg ulcers not yet completely healed
Legs – position
Right leg 22, left leg 21
Ulcer duration (n=28)
Mean 6,7 years (SD 10.49)
Duplex scan performed
29 out of the 43 patients
Compression therapy is the main treatment for venous leg ulceration. Compression bandages are used for oedema reduction and leg ulcer healing, while compression stockings are mainly are used as a preventative measure against the recurrence of oedema and venous leg ulceration.15 This study was performed in light of all the complications and lack of efficacy observed with the current treatment with compression stockings. In a survey involving physicians (n=154) in general surgery in Scotland, 32% (n=49) reported at least one case of damage induced by compression.16 According to Arpaia et al., 80% of all patients should, in theory, fit into a ready-made below-knee compression stockings.14 The local authorities in Denmark have estimated that 80% of the patients who require treatment with compression stockings (lymphedema patients included) can fit into readymade compression stockings. These stockings can only prevent and remove oedema within the range of the size of the brand given to the patient and therefore the actual measurement of the compression stocking are performed when the patient is free of oedema. However, in Denmark we have no standard criteria for the clinical assessment of oedema of
Table 6. Number of patients and how many measuring points within range of one size, out of three, in each brand Number of measuring point fitting into the different brands
Brand A n= 43
Brand B n=43
Brand C n=43
3
23
15
0
2
19
18
9
1
1
9
28
0
0
1
6
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Size chart with circumference ranges at all measurement points and sizes (cm)
were also included in final analyses (per-protocol/PP population). The data were collected over 4 weeks, and were analysed using SPSS, version 13.
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Table 3. Brand 2 Egertina Goslar
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Number of measuring point fitting into the different brands
Brand A n=43
Brand B n=43
Brand C n=43
7
2
3
0
6
7
4
0
5
13
13
0
4
17
9
3
3
4
13
11
2
0
1
21
1
0
0
8
Table 8. Statistics of each measuring point Standard Circumference Measurments (cm)
Median n=43
Minimum –Maximum n=43
10 percentile n=43
90 percentile n=43
cA
24.0
21.0 – 38.0
21.7
27.0
cY
34.0
28.0 – 41.5
31.0
38.8
cB
23.0
17.0 – 32.0
19.4
27.6
cB1
24.0
19.5 – 39.0
22.5
35.6
cC
35.0
26.0 – 51.0
29.1
46.3
cD
37.0
29.0 – 51.0
31.7
48.0
A-D
42.0
34.0 – 50.0
35.4
47.0
Table 9.The allocation of patients, illustrated in percentages, that fits the three brands using the 3 and 7 point measuring method. Brand A (9 sizes in 2 length)
Brand B (5 sizes in 3 length)
Brand C (6 sizes in 2 length)
3 point measurements
53.5 %
34.9%
0%
7 point measurements
4.7%
7.0%
0%
the lower legs. Therefore the assessment of when the patient’s legs are free of oedema is purely an individual clinical decision, made by different health care professionals. In this study, all patients were clinical assessed by the same experienced physicians and the same wound care nurse performed the measurements. In this study, the three and the seven point measurement protocol, was employed; however, why two different measuring methods exist is not clear. There are furthermore no guidelines to when, where, who and how the two different methods are to be used and if one method is preferred to the other. This decision, therefore, is completely based on the experience and knowledge of the person performing the measurements. There is a huge discrepancy in our results between the two measuring methods. This discrepancy suggests that the two measuring methods are not suited to select ready134
made compression stocking and furthermore ready-made compression stockings are not suited to be used in patients suffering from venous leg ulcers. The measuring method used to select the most accurate size of ready-made compression stockings may therefore play an important role in the rate of recurrence. Our results are comparable to a clinical questionnaire study from Italy.14 This study reported that only between 16–50% of the patients treated for venous leg ulceration could benefit from the treatment with ready-made compression stockings. The problem may be that ready made compression stockings are produced in standard sizes with a minimum and maximum circumference range and length, at internationally agreed measuring points, but based on an average of measurements in healthy volunteers, and not in venous leg ulcer patients.11,12 Another problem may be that the range of sizes may differ between companies and brands. In total, only 29 patients in this study were confirmed to exhibit venous leg ulceration by duplex scan and the remainder of the patients were diagnosed clinically, where ischemia was excluded. A mean value of 6.7 years for ulcer duration confirmed that the group of patients in this study all exhibited hard-to-heal venous leg ulcers. Shiman et al.17 described chronic venous insufficiency as a complex disease with venous ulceration, neuropathy, affected mobility and range of motion and gate abnormalities, which affects the calf muscle function. In addition, Yang et al.18 found a significant impairment of calf muscle function in patients with chronic venous insufficiency, compared with healthy control subjects. Venous hypertension and venous leg ulcers can cause leg muscle atrophy, and about half of the patients who have been treated for a venous leg ulcer can have changes in leg proportion. This results in a situation where the venous leg ulcer patients with severe changes in calf muscle and leg proportions are treated with ready-made compression stockings in sizes manufactured to fit only healthy individuals.12 This may offer a possible explanation for the discrepancy in our results between the two measuring methods, and the low amount of patients that could fit into ready-made compression stockings in our study. The other important issue is how the measurements for selection of ready-made below-knee compression stockings below knee are performed. Accurate measurements are important to ensure that the chosen type of compression stocking fits well and is comfortable to wear, in order to promote good compliance.15 If the stockings do not properly fit due to inaccurate measurements, it will result in discomfort for the patient, potential trauma, further ulceration and a waste of resources.18 This raises several questions:
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Table 7. Number of patients and how many measuring points within range of one size, out of 7, in each brand.
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practice Conclusion
• Firstly, is it possible to make ready-made belowknee compressions stockings which will fit a significant number of venous leg ulcer patients, or will each patient need to have a tailor-made stocking? • Would ready-made below-knee stockings better fit the patients if the compression stockings are manufactured in sizes based on venous leg ulcer patients? • Finally, what is the most simple but adequate measuring method available for selecting readymade stockings below knee? Is a measuring method with only 2 circumference measurements adequate or is more circumference measurements needed? Also where are the most optimal anatomical places to measure? Future studies are needed to answer these questions and to improve the outcome of using ready-made below knee compression stockings.
The results of this study show that using the three point measuring method for selection of ready- made compression stockings only fits at most 53.5% of patients and not 80% of the venous leg ulcer patients, as previously proposed.14 Using the seven point measuring method, the comparable figures was 0%–4.7%. There is a need for standardised measuring methods in the selection of ready-made compression stockings and a need for an evaluation of the present sizes in compression stockings, in relation to the anatomy of the venous leg ulcer patient. At present, these stockings will not properly fit and be effective in preventing oedema and ulcer recurrence in the majority of patients. Further studies focused on standardising sizes or the implementation of changes in fitting recommendations may help in preventing ulcer recurrence in patients. n
References 1 Gottrup, F., Holstein, P., Jørgensen, B., et al. A new concept of a multidisciplinary wound healing center and a national expert function of wound healing. Arch Surg 2001; 136: 7, 765–772. 2 Trent, J.T., Falabella, A., Eaglstein, W.H., Kirsner, R.S.Venous ulcers: pathophysiology treatment options. Ostomy wound manage 2005; 51: 5, 38–54. 3 Simon, D.A., Dix, F.P., McCollum, C.N. Management of venous leg ulcers. BMJ 2004; 328: 7452, 1358–1362. 4 O`Meara, S., Cullum, N.A., Nelson, E.A. Compression for venous leg ulcers. Cochrane Database Syst Rev 2009; 21: 1, CD000265. 5 Moffatt, C. Compression therapy in practice. Wounds UK, Aberdeen, 2007. 6 Nelson, E.A., Bell-Syer, S.E.
10 Nelson, E.A., Harper, D.R., Prescott, R.J., et al. Prevention of recurrence of venous ulceration: Randomized controlled trial class 2 and 3 elastic compression. J Vasc Surg 2006; 44: 4, 803–808. 11 Lymphoedema Framework: Template for Practice: compression hosiery in lymphoedema. London: MEP Ltd, 2006. 12 Partsch, H., Rabe, E., Stemmer, R. Compression therapy of the extremities. Paris: Editions Phlebologiques Francaises, 1999. 13 Wong, I.K., Man, M.B., Chan, O.S., et al. Comparison of the interface pressure and stiffness of four types of compression systems. J Wound Care 2012; 21: 4, 161–167. 14 Arpaia, G., Milani, M., Addeo, R. et al. Clinical validation of a specially sized class ll compression knee-sock for the prevention of recurrent ulcers in
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patients with chronic venous stasis. Int Angiol 2008; 27: 6, 507–511. 15 Williams, C. Leg ulcer after care: the role of compression hosiery. Br J Nurs 2000; 9: 13, 822–828. 16 Callam, M.J., Ruckley, C.V., Dale, J.J., Harpe, D.R. Hazards of compression treatment of the leg: an estimate from Scottish surgeons. Br Med J 1987; 28: 295, 6610, 1382. 17 Shiman, M.I., Pieper, B., Templin, T.N., et al. A reappraisal analyzing the effects of neuropathy, muscle involvement, and range of motion upon gait and calf muscle function. Wound Repair Regen 2009; 17: 2, 147–152. 18 Yang, D.,Vandongen,Y.K., Stacey, M.C. Changes in calf muscle function in chronic venous disease. Cardiovasc Surg 1999; 7: 4, 451–456.
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Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev 2012; 15: 8, CD002303. 7 Clarke-Moloney, M., Keane, N., O’Connor,V., et al. Randomized controlled trial comparing European standard class 1 to class 2 compression stockings for ulcer recurrence and patient compliance. Int Wound J 2012; 19 [Epub ahead of print]. 8 Moffatt Christine, Kommala Dheerendra, Choe Yoonhee. Venous leg ulcers: Patient concordance with compression therapy and its impact on healing and prevention of recurrence. Int Wound J 2009;6:386-393 9 Jull, A.B., Mitchell, N., Arroll, J., et al. Factors influencing concordance with compression stockings after venous leg ulcer healing. J Wound Care 2004; 13: 3, 90–92.
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