j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 3 6 6 e3 7 2
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Long-term outcomes of extracorporeal shockwave therapy for chronic foot ulcers Ching-Jen Wang, MD,a,b,* Cheng-Ta Wu, MD,b Ya-Ju Yang, BS,b Rue-Tsuan Liu, MD,c and Yur-Ren Kuo, MD, PhDa,d a
Center of Shockwave Medicine and Tissue Engineering, Department of Medical Research, Chang Gung University College of Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan b Department of Orthopedic Surgery, Chang Gung University College of Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan c Division of Endocrinology and Metabolism, Chang Gung University College of Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan d Department of Plastic and Reconstructive Surgery, Chang Gung University College of Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
article info
abstract
Article history:
Background: Recent studies showed that extracorporeal shockwave therapy (ESWT) is
Received 12 November 2013
effective in the treatment of chronic foot ulcers in short term. However, the long-term
Received in revised form
effects of ESWT in chronic foot ulcers are unknown. The purpose of this study was to
12 February 2014
evaluate the long-term outcomes of ESWT in chronic foot ulcers with 5-y follow-up.
Accepted 3 March 2014
Methods: The study cohort consisted of 67 patients with 72 ulcers including 38 patients with
Available online 11 March 2014
40 ulcers in the diabetes mellitus (DM) group and 29 patients with 32 ulcers in the none diabetes mellitus (non-DM) group. Each patient received ESWT to the affected foot twice
Keywords:
per week for 3 wk for a total of six treatments. The evaluations included clinical assessment
Long-term outcomes
for the ulcer status, local blood flow perfusion, and analysis of mortality and morbidity.
ESWT
Results: The results showed completely healed ulcers in 55.6% and 57.4% of total series, 48%
Chronic foot ulcers
and 43% of DM group, and 66% and 71% of non-DM group at 1 and 5 y (P ¼ 0.022 and P ¼ 0.027), respectively. The mortality rate was 15% in total series, 24% in DM group, and 3% in non-DM group (P ¼ 0.035). The rate of amputation was 11% in total series, 17% in DM group, and 3.6% in non-DM group (P ¼ 0.194). The blood flow perfusion rate significantly increased after ESWT for up to 1 yr but decreased from 1e5 y in both groups. However, the non-DM group showed significantly better blood flow perfusion than the DM group at 5 y (P ¼ 0.04). Conclusions: ESWT appears effective in chronic diabetic and nondiabetic foot ulcers. However, the effects decreased from 1e5 y after treatment. ª 2014 Elsevier Inc. All rights reserved.
1.
Introduction
Chronic foot ulcers are defined as nonhealing ulcers for >3 mo. The etiologies of chronic foot ulcers are multifactorial.
Diabetic ulcers are caused by small vessel occlusion angiopathy associated with poor skin sensation because of peripheral neuropathy and secondary infection. Nondiabetic ulcers are caused by venous stasis with poor venous return because
* Corresponding author. Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital, 123 Ta-Pei Road, Niao-Sung District, Kaohsiung 833, Taiwan. Tel.: þ1 886 7 733-5279; fax: þ1 886 7 733-5515. E-mail address: [email protected] (C.-J. Wang). 0022-4804/$ e see front matter ª 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2014.03.002
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 3 6 6 e3 7 2
of deep vein thrombosis or varicosity that predisposes to tissue edema, skin breakdown and secondary infection, and peripheral arterial disease [1,2]. Managements of chronic foot ulcers require multidisciplinary approaches including diabetic control, antibiotic, shoe wear, wound care, and surgery in selected cases. The results of surgical and nonsurgical treatments are inconsistent, and most studies reported unsatisfactory results [3e5]. Therefore, many adjunctive therapies are designed for the care of chronic foot ulcers including hyperbaric oxygen therapy (HBOT), ultrasound, recombinant human platelet-derived growth factor BB, vacuum-assisted wound closure, and acellular matrix. Some achieved limited success, but none showed universal results [6e13]. Recent study reported positive effects of extracorporeal shockwave therapy (ESWT) in the treatment of acute and chronic wounds [14]. Prior studies showed that ESWT is more effective than HBOT in the treatment of diabetic foot ulcers in short-term follow-up [15]. Other studies demonstrated that ESWT is effective in chronic foot ulcers [16e18]. Furthermore, ESWT was shown to improve the skin flap survival, healing of burn wound, and improvement in blood flow perfusion [19e21]. Yet, the long-term result of ESWT in chronic foot ulcers is unknown. The purpose of this study was to evaluate the long-term effects of ESWT in chronic foot ulcers with 1and 5-y follow-up. We hypothesized that ESWT may be effective in the treatment of chronic diabetic and nondiabetic foot ulcers in short- and long-term results.
Table 1 e The flow chart of patient recruitment.
from the wound perimeter in every direction. The treatment area is calculated as the actual size of the ulcer extending 1.0 cm in each direction.
2.2.
2.
Patients and methods
The institutional review board of our institution approved this prospective clinical study. The study was performed in accordance with the standard of the ethical committee, and the declaration of Helsinki protocol was followed. All patients were required to sign an informed consent before participation in the study. The inclusion criteria included patients with recurrent or persistent nonhealing diabetic or nondiabetic ulcers of the foot for >3 mo. The exclusion criteria included patients with cardiac arrhythmia or pacemaker, pregnancy, malignancy or joint sepsis, skeletal immaturity, and poor compliance. Seventy patients with 80 ulcers were initially screened for the study. Among them, 67 patients with 72 ulcers were assessed for eligibility. The study cohort included 38 patients with 40 ulcers in the diabetes mellitus (DM) group and 29 patients with 32 ulcers in the nonediabetes mellitus (nonDM) group. The flow chart of patient recruitment is shown in Table 1, and the patient demographic characteristics are listed in Table 2.
2.1.
Shockwave application
All patients received ESWT to the diseased foot. The source of shockwave was from a dermaPACE device (SANUWAVE, Alpharetta, GA). The treatment dosage is ulcer size dependent. The number of impulses ¼ treatment area (cm2) 8, but at least 500 shocks at E2 at 4 Hz (equivalent to 0.11 mJ/mm2 energy flux density) twice/wk for six treatments. During treatment, the treatment head of the device should be gently glided over the entire surface of the wound extending 1.0 cm
367
Complications
There were no systemic or neurovascular complications. There were no device-related problems. None of the ulcers became worse after ESWT. Two patients complained of transient burning sensation around the treatment area that resolved spontaneously within 1e2 d.
2.3.
Blood flow perfusion scan
Tissue viability was evaluated by local blood flow perfusion scan preoperatively and at 6 wk, 1 y, and 5 y postoperatively. Local blood flow perfusion was measured using the Peri-Scan PIM II Laser Doppler Perfusion Imager (Perimed AB, Stockholm, Sweden). The object was placed on a lightabsorbing background material such as a black or a dark green cloth. The distance between the scanner head and the object was 15 cm. The minimum and maximum values were set at 0 and 5 V, respectively. The perfusion scan image color scale displayed the lowest value in dark blue and the highest value in dark red. The minimal value, the maximal value, and the mean and standard deviation were computer analyzed. After treatment, all patients received the necessary medical care from the referring physicians, including diabetic control, wound dressing care, and antibiotic, if indicated. The follow-up examinations were performed in 1, 3, 6, and 12 mo and then once a year. The evaluations included clinical assessment of the ulcer status, including the size, shape, and depth with photo documentation, local blood flow perfusion scan, and the mortality and morbidity including the rates of amputation in 1 and 5 y after ESWT.
368
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 3 6 6 e3 7 2
Table 2 e Patient demographic characteristics.
Patients/lesions Average age (y), mean SD (range) Gender (males/females) Right/left Location of ulcer Dorsal Plantar Average ulcer size (cm2), mean SD (range) Average duration (mo), mean SD (range) Average HbA1c (%), mean SD (range) Average ABPI,* mean SD (range) ABPI 1.4 Smokers Obesity (BMI >30) Medications Cortisone Antibiotics *
Total
DM group
Non-DM group
P-value**
67/72 59.76 13.34 (18e81) 43/24 30/42
38/40 59.03 11.67 (33e81) 28/10 17/23
29/32 60.75 15.49 (18e77) 15/14 13/19
0.471 0.139 0.063 0.873
45 25 9.08 16.21 (0.15e84) 17.52 18.61 (3e72) 7.72 1.42 (5.4e10.6) 1.09 0.15 (0.84e1.62) 4/72 1/72 26/67 10/67
18 20 9.54 15.44 (0.15e75) 20.9 20.35 (3e72) 7.96 1.28 (6.4e10.6) 1.10 0.15 (0.84e1.62) 4/40 1/40 17/38 6/38
27 5 8.49 17.38 (0.5e84) 13.19 15.36 (3e60) 6.48 1.6 (5.4e9.3) 1.02 0.08 (0.94e1.12) 0/32 0/32 9/29 4/29
0.424 0.056 0.018 0.169 0.124 0.368 0.254 0.820
5/67 16/67
2/38 11/38
3/29 5/29
0.645 0.265
Ankle-brachial pressure index. The P-values were obtained by ManneWhitney test.
**
2.4.
Statistical analysis
The demographic data of DM and non-DM groups were compared statistically using ManneWhitney test. The overall clinical results between DM and non-DM groups at 1 and 5 y were statistically compared by chi-square test. The data of blood flow perfusion rate before treatment and at 6 wk, 1 y, and 5 y after treatment within the same group were compared using Friedman test. The blood flow perfusion rates of DM and non-DM groups were compared by ManneWhitney test. The mortality and morbidity between DM and non-DM groups at 1 and 5 y were compared statistically using chi-square test. A statistical significance was set at P < 0.05.
3.
Results
The overall clinical results at 3 mo, 1 y, and 5 y and the quality of life scale [22] are listed in Table 3. Sixty-seven patients with 72 ulcers were examined at 3 mo and 1 y. At 3 mo, healed and 50% improved ulcers were 55.6% in total series, 42.5% in the DM group, and 71.9% of the non-DM group (P ¼ 0.006). At 1 y, healed and 50% improved ulcers were 83.4% in total series, 73% in the DM group, and 97% in the non-DM group (P ¼ 0.022). Excluding 10 deaths (nine in the DM group and one in the non-DM group), 57 patients with 61 ulcers were evaluated at 5 y. Healed and 50% improved ulcers were 62.1% in total series, 46% in the DM group, and 77% in the non-DM group (P ¼ 0.027). The clinical results of the non-DM group were significantly better than those of the DM group at 3 mo (P ¼ 0.006), 1 y (P ¼ 0.027), and 5 y (P ¼ 0.022), respectively. In quality of life scale, the nonDM and the ESWT groups showed significantly better quality of life than the DM group (P < 0.001) and the HBOT group (P < 0.001), respectively.
The mortality and morbidity at 1 and 5 y are summarized in Table 4. Ten patients (nine in the DM group and one in the nonDM group) died that resulted in the mortality of 15% in total series, 24% in the DM group, and 3% in the non-DM group from 1e5 y after treatment. Twelve patients (8% or 20% in the DM group and 4% or 12.5% in the non-DM group) underwent surgical debridement and skin graft for nonhealing ulcers after ESWT, and these cases were classified as failure to ESWT treatment. Six patients (five in the DM group and one in the non-DM group) underwent amputation (three above the knee and three below the knee) because of refractory and progressive osteomyelitis in four patients and peripheral vascular occlusion in two patients. The amputation rates were 11% in total series, 17% in the DM group, and 4% in the non-DM group. The results of Doppler perfusion scan are listed in Table 5. After ESWT, the blood flow perfusion rates significantly improved in both DM (P ¼ 0.011) and non-DM (P ¼ 0.033) groups. The improvements of blood flow perfusion rate began at 6 wk and lasted for up to 1 y after ESWT. The blood perfusion rates significantly decreased in both groups from 1e5 y compared with the data before treatment, at 6 wk (P ¼ 0.006), and 1 y (P < 0.001). The blood flow perfusion rate of the nonDM group is significantly better than that of the DM group from 1e5 y after ESWT (P ¼ 0.04). The clinical outcomes, mortality, and morbidity of the current series are compared with the historical control data of 149 patients with diabetic foot ulcers treated at our hospital in 2004, and the results are summarized in Table 6. The current series showed better overall clinical outcomes of healed and improved ulcers at 1 y (73% versus 64.4%) compared with the historical controls, although the differences did not reach statistical significance (P ¼ 0.338). The mortality rate was 9.4% in the historical controls and 0% at 1 y (P ¼ 0.044) and 24% at 5 y (P ¼ 0.017) in the current series. The historical controls showed significantly higher amputation rates compared with the current series at 1 y (P < 0.001) and 5 y (P < 0.001) and more
369
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 3 6 6 e3 7 2
Table 3 e Overall clinical results at 1 and 5 y and QOL scale. Total At 3 mo Number of patients/ulcers Completely healed (%) 50% Improvement (%) Unchanged or worse (%) P-value2 (group total) At 1 y Number of patients/ulcers Completely healed (%) 50% Improvement (%) Unchanged or worse (%) P-value2 (group total) At 5 y Number of patients/ulcers Completely healed (%) 50% Improvement (%) Unchanged (%) Failure (%) P-value2 (group total) QOL scale DM versus non-DM Mean SD (range) ESWT versus HBOT Mean SD (range) -1
DM
P-value1
Non-DM
67/72 27/72 (37.5) 13/72 (18.1) 32/72 (44.4)
38/40 8/40 (20) 9/40 (22.5) 23/40 (57.5)
29/32 19/32 (59.4) 4/32 (12.5) 9/32 (28.1)
67/72 40/72 (55.6) 20/72 (27.8) 12/72 (6.7)
38/40 19/40 (48) 10/40 (25) 11/40 (28)
29/32 21/32 (66) 10/32 (31) 1/32 (3)
57/61 35/61 (57.4) 3/61 (4.7) 11/61 (18) 12/61 (19.7)
29/30 13/30 (43) 1/30 (3) 8/30 (27) 8/30 (27)
28/31 22/31 (71) 2/31 (6) 3/31 (10) 4/31 (13)
Total (N ¼ 67) 67.8 4.9 (58e80) Total (N ¼ 103) 64.7 5.6 (53e80)
DM 65.7 4.2 ESWT 67.6 4.9
(N ¼ 38) (58e72) (N ¼ 67) (58e80)
non-DM 70.6 4.4 HBOT 60.3 3.3
0.009 0.273 0.013 0.006
0.124 0.556 0.006 0.022
0.029 0.577 0.084 0.176 0.027
(N ¼ 29) (58e80) (N ¼ 36) (53e65)
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Long-term outcomes of extracorporeal shockwave therapy for chronic foot ulcers Ching-Jen Wang, MD,a,b,* Cheng-Ta Wu, MD,b Ya-Ju Yang, BS,b Rue-Tsuan Liu, MD,c and Yur-Ren Kuo, MD, PhDa,d a
Center of Shockwave Medicine and Tissue Engineering, Department of Medical Research, Chang Gung University College of Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan b Department of Orthopedic Surgery, Chang Gung University College of Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan c Division of Endocrinology and Metabolism, Chang Gung University College of Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan d Department of Plastic and Reconstructive Surgery, Chang Gung University College of Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
article info
abstract
Article history:
Background: Recent studies showed that extracorporeal shockwave therapy (ESWT) is
Received 12 November 2013
effective in the treatment of chronic foot ulcers in short term. However, the long-term
Received in revised form
effects of ESWT in chronic foot ulcers are unknown. The purpose of this study was to
12 February 2014
evaluate the long-term outcomes of ESWT in chronic foot ulcers with 5-y follow-up.
Accepted 3 March 2014
Methods: The study cohort consisted of 67 patients with 72 ulcers including 38 patients with
Available online 11 March 2014
40 ulcers in the diabetes mellitus (DM) group and 29 patients with 32 ulcers in the none diabetes mellitus (non-DM) group. Each patient received ESWT to the affected foot twice
Keywords:
per week for 3 wk for a total of six treatments. The evaluations included clinical assessment
Long-term outcomes
for the ulcer status, local blood flow perfusion, and analysis of mortality and morbidity.
ESWT
Results: The results showed completely healed ulcers in 55.6% and 57.4% of total series, 48%
Chronic foot ulcers
and 43% of DM group, and 66% and 71% of non-DM group at 1 and 5 y (P ¼ 0.022 and P ¼ 0.027), respectively. The mortality rate was 15% in total series, 24% in DM group, and 3% in non-DM group (P ¼ 0.035). The rate of amputation was 11% in total series, 17% in DM group, and 3.6% in non-DM group (P ¼ 0.194). The blood flow perfusion rate significantly increased after ESWT for up to 1 yr but decreased from 1e5 y in both groups. However, the non-DM group showed significantly better blood flow perfusion than the DM group at 5 y (P ¼ 0.04). Conclusions: ESWT appears effective in chronic diabetic and nondiabetic foot ulcers. However, the effects decreased from 1e5 y after treatment. ª 2014 Elsevier Inc. All rights reserved.
1.
Introduction
Chronic foot ulcers are defined as nonhealing ulcers for >3 mo. The etiologies of chronic foot ulcers are multifactorial.
Diabetic ulcers are caused by small vessel occlusion angiopathy associated with poor skin sensation because of peripheral neuropathy and secondary infection. Nondiabetic ulcers are caused by venous stasis with poor venous return because
* Corresponding author. Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital, 123 Ta-Pei Road, Niao-Sung District, Kaohsiung 833, Taiwan. Tel.: þ1 886 7 733-5279; fax: þ1 886 7 733-5515. E-mail address: [email protected] (C.-J. Wang). 0022-4804/$ e see front matter ª 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jss.2014.03.002
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 3 6 6 e3 7 2
of deep vein thrombosis or varicosity that predisposes to tissue edema, skin breakdown and secondary infection, and peripheral arterial disease [1,2]. Managements of chronic foot ulcers require multidisciplinary approaches including diabetic control, antibiotic, shoe wear, wound care, and surgery in selected cases. The results of surgical and nonsurgical treatments are inconsistent, and most studies reported unsatisfactory results [3e5]. Therefore, many adjunctive therapies are designed for the care of chronic foot ulcers including hyperbaric oxygen therapy (HBOT), ultrasound, recombinant human platelet-derived growth factor BB, vacuum-assisted wound closure, and acellular matrix. Some achieved limited success, but none showed universal results [6e13]. Recent study reported positive effects of extracorporeal shockwave therapy (ESWT) in the treatment of acute and chronic wounds [14]. Prior studies showed that ESWT is more effective than HBOT in the treatment of diabetic foot ulcers in short-term follow-up [15]. Other studies demonstrated that ESWT is effective in chronic foot ulcers [16e18]. Furthermore, ESWT was shown to improve the skin flap survival, healing of burn wound, and improvement in blood flow perfusion [19e21]. Yet, the long-term result of ESWT in chronic foot ulcers is unknown. The purpose of this study was to evaluate the long-term effects of ESWT in chronic foot ulcers with 1and 5-y follow-up. We hypothesized that ESWT may be effective in the treatment of chronic diabetic and nondiabetic foot ulcers in short- and long-term results.
Table 1 e The flow chart of patient recruitment.
from the wound perimeter in every direction. The treatment area is calculated as the actual size of the ulcer extending 1.0 cm in each direction.
2.2.
2.
Patients and methods
The institutional review board of our institution approved this prospective clinical study. The study was performed in accordance with the standard of the ethical committee, and the declaration of Helsinki protocol was followed. All patients were required to sign an informed consent before participation in the study. The inclusion criteria included patients with recurrent or persistent nonhealing diabetic or nondiabetic ulcers of the foot for >3 mo. The exclusion criteria included patients with cardiac arrhythmia or pacemaker, pregnancy, malignancy or joint sepsis, skeletal immaturity, and poor compliance. Seventy patients with 80 ulcers were initially screened for the study. Among them, 67 patients with 72 ulcers were assessed for eligibility. The study cohort included 38 patients with 40 ulcers in the diabetes mellitus (DM) group and 29 patients with 32 ulcers in the nonediabetes mellitus (nonDM) group. The flow chart of patient recruitment is shown in Table 1, and the patient demographic characteristics are listed in Table 2.
2.1.
Shockwave application
All patients received ESWT to the diseased foot. The source of shockwave was from a dermaPACE device (SANUWAVE, Alpharetta, GA). The treatment dosage is ulcer size dependent. The number of impulses ¼ treatment area (cm2) 8, but at least 500 shocks at E2 at 4 Hz (equivalent to 0.11 mJ/mm2 energy flux density) twice/wk for six treatments. During treatment, the treatment head of the device should be gently glided over the entire surface of the wound extending 1.0 cm
367
Complications
There were no systemic or neurovascular complications. There were no device-related problems. None of the ulcers became worse after ESWT. Two patients complained of transient burning sensation around the treatment area that resolved spontaneously within 1e2 d.
2.3.
Blood flow perfusion scan
Tissue viability was evaluated by local blood flow perfusion scan preoperatively and at 6 wk, 1 y, and 5 y postoperatively. Local blood flow perfusion was measured using the Peri-Scan PIM II Laser Doppler Perfusion Imager (Perimed AB, Stockholm, Sweden). The object was placed on a lightabsorbing background material such as a black or a dark green cloth. The distance between the scanner head and the object was 15 cm. The minimum and maximum values were set at 0 and 5 V, respectively. The perfusion scan image color scale displayed the lowest value in dark blue and the highest value in dark red. The minimal value, the maximal value, and the mean and standard deviation were computer analyzed. After treatment, all patients received the necessary medical care from the referring physicians, including diabetic control, wound dressing care, and antibiotic, if indicated. The follow-up examinations were performed in 1, 3, 6, and 12 mo and then once a year. The evaluations included clinical assessment of the ulcer status, including the size, shape, and depth with photo documentation, local blood flow perfusion scan, and the mortality and morbidity including the rates of amputation in 1 and 5 y after ESWT.
368
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 3 6 6 e3 7 2
Table 2 e Patient demographic characteristics.
Patients/lesions Average age (y), mean SD (range) Gender (males/females) Right/left Location of ulcer Dorsal Plantar Average ulcer size (cm2), mean SD (range) Average duration (mo), mean SD (range) Average HbA1c (%), mean SD (range) Average ABPI,* mean SD (range) ABPI 1.4 Smokers Obesity (BMI >30) Medications Cortisone Antibiotics *
Total
DM group
Non-DM group
P-value**
67/72 59.76 13.34 (18e81) 43/24 30/42
38/40 59.03 11.67 (33e81) 28/10 17/23
29/32 60.75 15.49 (18e77) 15/14 13/19
0.471 0.139 0.063 0.873
45 25 9.08 16.21 (0.15e84) 17.52 18.61 (3e72) 7.72 1.42 (5.4e10.6) 1.09 0.15 (0.84e1.62) 4/72 1/72 26/67 10/67
18 20 9.54 15.44 (0.15e75) 20.9 20.35 (3e72) 7.96 1.28 (6.4e10.6) 1.10 0.15 (0.84e1.62) 4/40 1/40 17/38 6/38
27 5 8.49 17.38 (0.5e84) 13.19 15.36 (3e60) 6.48 1.6 (5.4e9.3) 1.02 0.08 (0.94e1.12) 0/32 0/32 9/29 4/29
0.424 0.056 0.018 0.169 0.124 0.368 0.254 0.820
5/67 16/67
2/38 11/38
3/29 5/29
0.645 0.265
Ankle-brachial pressure index. The P-values were obtained by ManneWhitney test.
**
2.4.
Statistical analysis
The demographic data of DM and non-DM groups were compared statistically using ManneWhitney test. The overall clinical results between DM and non-DM groups at 1 and 5 y were statistically compared by chi-square test. The data of blood flow perfusion rate before treatment and at 6 wk, 1 y, and 5 y after treatment within the same group were compared using Friedman test. The blood flow perfusion rates of DM and non-DM groups were compared by ManneWhitney test. The mortality and morbidity between DM and non-DM groups at 1 and 5 y were compared statistically using chi-square test. A statistical significance was set at P < 0.05.
3.
Results
The overall clinical results at 3 mo, 1 y, and 5 y and the quality of life scale [22] are listed in Table 3. Sixty-seven patients with 72 ulcers were examined at 3 mo and 1 y. At 3 mo, healed and 50% improved ulcers were 55.6% in total series, 42.5% in the DM group, and 71.9% of the non-DM group (P ¼ 0.006). At 1 y, healed and 50% improved ulcers were 83.4% in total series, 73% in the DM group, and 97% in the non-DM group (P ¼ 0.022). Excluding 10 deaths (nine in the DM group and one in the non-DM group), 57 patients with 61 ulcers were evaluated at 5 y. Healed and 50% improved ulcers were 62.1% in total series, 46% in the DM group, and 77% in the non-DM group (P ¼ 0.027). The clinical results of the non-DM group were significantly better than those of the DM group at 3 mo (P ¼ 0.006), 1 y (P ¼ 0.027), and 5 y (P ¼ 0.022), respectively. In quality of life scale, the nonDM and the ESWT groups showed significantly better quality of life than the DM group (P < 0.001) and the HBOT group (P < 0.001), respectively.
The mortality and morbidity at 1 and 5 y are summarized in Table 4. Ten patients (nine in the DM group and one in the nonDM group) died that resulted in the mortality of 15% in total series, 24% in the DM group, and 3% in the non-DM group from 1e5 y after treatment. Twelve patients (8% or 20% in the DM group and 4% or 12.5% in the non-DM group) underwent surgical debridement and skin graft for nonhealing ulcers after ESWT, and these cases were classified as failure to ESWT treatment. Six patients (five in the DM group and one in the non-DM group) underwent amputation (three above the knee and three below the knee) because of refractory and progressive osteomyelitis in four patients and peripheral vascular occlusion in two patients. The amputation rates were 11% in total series, 17% in the DM group, and 4% in the non-DM group. The results of Doppler perfusion scan are listed in Table 5. After ESWT, the blood flow perfusion rates significantly improved in both DM (P ¼ 0.011) and non-DM (P ¼ 0.033) groups. The improvements of blood flow perfusion rate began at 6 wk and lasted for up to 1 y after ESWT. The blood perfusion rates significantly decreased in both groups from 1e5 y compared with the data before treatment, at 6 wk (P ¼ 0.006), and 1 y (P < 0.001). The blood flow perfusion rate of the nonDM group is significantly better than that of the DM group from 1e5 y after ESWT (P ¼ 0.04). The clinical outcomes, mortality, and morbidity of the current series are compared with the historical control data of 149 patients with diabetic foot ulcers treated at our hospital in 2004, and the results are summarized in Table 6. The current series showed better overall clinical outcomes of healed and improved ulcers at 1 y (73% versus 64.4%) compared with the historical controls, although the differences did not reach statistical significance (P ¼ 0.338). The mortality rate was 9.4% in the historical controls and 0% at 1 y (P ¼ 0.044) and 24% at 5 y (P ¼ 0.017) in the current series. The historical controls showed significantly higher amputation rates compared with the current series at 1 y (P < 0.001) and 5 y (P < 0.001) and more
369
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 9 ( 2 0 1 4 ) 3 6 6 e3 7 2
Table 3 e Overall clinical results at 1 and 5 y and QOL scale. Total At 3 mo Number of patients/ulcers Completely healed (%) 50% Improvement (%) Unchanged or worse (%) P-value2 (group total) At 1 y Number of patients/ulcers Completely healed (%) 50% Improvement (%) Unchanged or worse (%) P-value2 (group total) At 5 y Number of patients/ulcers Completely healed (%) 50% Improvement (%) Unchanged (%) Failure (%) P-value2 (group total) QOL scale DM versus non-DM Mean SD (range) ESWT versus HBOT Mean SD (range) -1
DM
P-value1
Non-DM
67/72 27/72 (37.5) 13/72 (18.1) 32/72 (44.4)
38/40 8/40 (20) 9/40 (22.5) 23/40 (57.5)
29/32 19/32 (59.4) 4/32 (12.5) 9/32 (28.1)
67/72 40/72 (55.6) 20/72 (27.8) 12/72 (6.7)
38/40 19/40 (48) 10/40 (25) 11/40 (28)
29/32 21/32 (66) 10/32 (31) 1/32 (3)
57/61 35/61 (57.4) 3/61 (4.7) 11/61 (18) 12/61 (19.7)
29/30 13/30 (43) 1/30 (3) 8/30 (27) 8/30 (27)
28/31 22/31 (71) 2/31 (6) 3/31 (10) 4/31 (13)
Total (N ¼ 67) 67.8 4.9 (58e80) Total (N ¼ 103) 64.7 5.6 (53e80)
DM 65.7 4.2 ESWT 67.6 4.9
(N ¼ 38) (58e72) (N ¼ 67) (58e80)
non-DM 70.6 4.4 HBOT 60.3 3.3
0.009 0.273 0.013 0.006
0.124 0.556 0.006 0.022
0.029 0.577 0.084 0.176 0.027
(N ¼ 29) (58e80) (N ¼ 36) (53e65)
