545876

research-article2014

IJLXXX10.1177/1534734614545876The International Journal of Lower Extremity WoundsPiaggesi et al.

Original Paper

Do You Want to Organize a Multidisciplinary Diabetic Foot Clinic? We Can Help

The International Journal of Lower Extremity Wounds 2014, Vol. 13(4) 363­–370 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1534734614545876 ijl.sagepub.com

Alberto Piaggesi, MD1, Alberto Coppelli, MD1, Chiara Goretti, MD1, Elisabetta Iacopi, MD1, and Chiara Mattaliano, MD1

Abstract The diabetic foot (DF) is a complex pathology involving the lower limb of 8 to 10 million people around the world, and its prevalence is rising, creating a dramatic need for effective therapeutic answers. The multidisciplinary DF clinic has been proposed as a model to fight this complication from the International Working Group on Diabetic Foot (IWGDF) inside a more articulated 3-level organization strategy. The organization and technical aspects of this strategy, together with the characteristics of each of the 3 levels have been analyzed and described in the article, together with the aims and limitations of each of the levels to cope with a 3-dimensional pathology involving systemic, local, and logistic aspects. The implementation of this model in Europe produced positive results measured so far in at least 2 nationwide experiences, in Germany and in Italy, and it should be taken in account whenever health policies apply to the DF issue. Keywords diabetic foot, delivery of care, organization, implementation Diabetic foot (DF) problems affect almost 1 out of 4 diabetic patients at least once in their lifetime, and, because of the increasing prevalence of the disease and the worsening pattern of the pathology, the incidence of this complication is expected to rise up to 5-fold in the coming years.1,2 At variance with many other chronic ulcerative conditions, DF is not a local disease related with a single pathogenic factor, but represents the manifestation at the level of an organ—the lower limb—of the multiple systemic complications of a chronic progressive systemic disease—diabetes mellitus.3,4 Diabetic foot still represents the most prevalent cause of amputation of the lower limbs on planet earth, is characterized by a multi-organ comorbidity and is associated with a mortality that is as high as many forms of cancer.5,6 The complexity of the disease, its multicomponent pathogenesis, the interconnection between local and systemic aspects, its asymptomatic clinical profile, and its aggressiveness make DF the major task for the diabetologists; one that cannot be accomplished without an adequate organization of care, which could enable the clinicians to respond with a panel of effective solutions to the many different needs of the DF patient. The International Working Group on Diabetic Foot (IWGDF), in a consensus-building process based on the criteria of the evidence-based medicine (EBM) that is going on since 15 years, released 4 editions on the Consensus on

Diabetic Foot Guidelines, which represent the standard of care in the field and that should be adopted by anyone who wishes to establish or implement a clinical activity on DF.7 At the basis of the IWGDF approach there are 2 fundamental concepts, which are related to crucial aspect of the pathology: the multidisciplinary team approach and the organization of care according to the different levels of complexity of the disease.8 In this article, we will try to apply the model described in the IWGDF guidelines to the variety of conditions that the clinicians face in their everyday work on DF.

The Characteristics of the Disease: Diabetic Foot Is Forever Diabetic foot is the final result of a long process, which starts with the beginning of the metabolic derangements that affect all the structures of our organism slowly progressing toward functional and then organic involvement of many different systems and organs; in the case of lower 1

Azienda Ospedaliera Universitaria Pisana, Pisa, Italy

Corresponding Author: Alberto Piaggesi, Diabetic Foot Section, Department of Medicine, Azienda Ospedaliera Universitaria Pisana, Via Paradisa 2, 56124 Pisa, Italy. Email: [email protected]

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Figure 1.  The pathogenesis of the diabetic foot. In each phase, the patient’s conditions have different needs and deserve different therapeutic approaches, all integrated in a complex strategy.

limbs, the systems that are involved and that create the conditions for the pathology to develop are the peripheral nervous system, the peripheral vascular system, and the immune system.9 The impairment of these components slowly progresses through an initial asymptomatic phase, called “preulcerative phase,” during which there are the condition for developing the DF pathology yet without any organ involvement. This shifts to an acute “ulcerative phase” in which, most likely for the consequences of a minor traumatic accident, the pathology localizes at the level of the foot, most frequently with a ulceration, which may complicate with an infection, with a necrosis, or both. This is usually followed by a “postulcerative phase” in which the patient, both as a consequence of the pathology or for the therapeutic intervention, is at high risk for recurrences, and may bear the consequences of minor or major amputations10 (Figure 1). The time frames of the 3 phases are very different, though. Usually, it takes many years before the at-risk patient develops the acute phase, which in turn may be dramatically sudden and eventually assume the characteristics of an emergency. The postulcerative phase is usually characterized by an alternation of chronic periods and acute recurrences, each of which worsens the condition of the patient. According to this scheme, the DF patients during the progression of the pathology actually present different patterns of the disease, with different needs that deserve different therapeutic approaches: in the first phase, the screening and quantitation of the different components—vascular, neuropathic—and the treatment of risk factors should be the target of the treatment, in order to prevent as much as possible the progression of the disease. In this phase, the medical aspects of the pathology are more prominent and the aggressive control of the underlying dysmetabolic condition should be the focus of the intervention.11

In the acute phase, where the pathology has determined local lesions, either ulceration or bone fractures, often complicated by infection, surgery and local measures have the prominence, associated with an adequate systemic care to stabilize the multicomplicated patient, which frequently must be admitted and managed in an in-hospital setting.12 In the postulcerative phase, the needs of the patients include the necessity of adequate offloading to protect the foot at high risk against recurrent traumas, and a timely follow-up of the outcomes of the procedures and of their consequences, either on the vascular and biomechanical side, to early detect any further sign of evolution of the pathology and to adequately intervene.13 In any phase the systemic conditions of the patients are relevant to determine the outcomes of the interventions and the prognosis of the patient, both for amputation and death, since they have been identified as predictors of outcomes in recent prospective studies.6 The progression of the DF pathology actually could be represented by a spiral progressing from the diagnosis of diabetes to the amputation and eventually death, increasing its width, proportionally with the increasing risk, at any acute phase episode, which should be considered a marker of severity of the progression of the disease.

The Organization in Levels: The More Severe the Pathology, the More Complex the Care According to the synthetic description of the natural history of the disease, an organizational model for the care of DF has been developed by IWGDF and proposed in the Consensus guidelines as a paradigm to be implemented at national and regional levels.14 The model is shaped as a network of centers at different levels of complexity, which should be interconnected, in order to properly address the cases according to their severity: the first level, the one at the lower level of complexity is identified with the general practitioners’ network and general diabetic clinics; the second level, at an intermediate level of complexity, represents the local hospital-based dedicated units, while the third level is represented by the referral level, usually located in the teaching hospitals, with a multidisciplinary team (Figure 2).

The First Level The role of the first level is to actively screen the lower limb complication in the diabetic population, identifying and stratifying the patients according to the ulcerative risk factor score, like it has been defined in the IWGDF guidelines (Table 1).

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Figure 2.  The model of the organization of the diabetic foot clinics into 3 integrated levels, according to the International Working Group on Diabetic Foot (IWGDF) guidelines. Table 1.  The International Working Group on Diabetic Foot Classification for the Ulcerative Risk.a Class 0 1 2 3

Risk Absent Medium High

Definition

Follow-up

No neuropathy Sensitive neuropathy Sensitive neuropathy and vascular disease and/or foot deformities Very high Previous ulcer or amputation

Yearly Every 6 months Every 3 months Monthly

a With each condition is associated a score that defines the severity of the risk and the corresponding follow-up.

Treating the risk factors and educating the patients in order to reduce the progression of the pathology as much as possible is the target of the first level, together with the follow-up, which should be scheduled according to the severity of the risk score, the more severe the risk, the more frequent the follow-up.15 In case of the finding of an acute case, it should be referred to a second level centre, for the diagnosis and therapeutic program, and then managed together, if not severe at the point that it requires admission.

The Second Level In the second-level units, in which a diabetologist and a podologist should be the minimal team, the second-level diagnostics—such as duplex scanning and x-rays—and the management of acute phases in conjunction with the first-level centers in case of noncomplicated cases or with

third-level centers in case of complicated cases should be delivered. The pathologies that second-level centers are committed to manage are the acute lesions graded IA/IB, IIA/IIB according to the Texas University Score, while they should refer the others to tertiary centers. The second-level units should be capable of delivering targeted antibacterial therapy adjusted on cultures from the lesions, adequate offloading, including total contact casting (TCC) or removable device walkers rendered irremovable, local care, negative pressure wound therapy, basic surgical procedures, like superficial abscess drainage or nail care, debridement, and podiatric care.16,17 For secondary prevention second-level units should also be able to prescribe and check the manufacturing of orthoses and shoes in primary and secondary prevention, according to the needs of the patients, possibly following evidence-based protocols.18,19

The Third Level The third-level centers, the referral-level units, are the most specialized link of the chain and should be adequately equipped and staffed to manage the most difficult cases: IIIA/IIIB and all the C and D cases. The referral-level units should deliver revascularizations, surgical interventions, Charcot’s foot management, and cope with urgent referral cases. Referral-level units should have in-hospital facilities where to admit patients who need interventional procedures or intravenous antibiotic therapy, and should have access to magnetic resonance imaging and all the diagnostic and therapeutic options that may be necessary to manage complex cases, also on the internal medicine side.

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Table 2.  The Texas University Score for the Classification of the Ulceration of Diabetic Foot.a 0

I

II

III

A

No open lesion

Superficial ulcer

Ulcer deep to fascia, tendon or joint

Ulcer penetrating joint or bone

B

+ Infection

+ Infection

+ Infection

+ Infection

C

+ Ischemia

+ Ischemia

+ Ischemia

+ Ischemia

D

+ Ischemia and infection

+ Ischemia and infection

+ Ischemia and infection

+ Ischemia and infection

 First level 

Second level 

Third level

a

For each stage a code in color has been associated according to the level of management.

The third-level team should comprise a diabetologist as coordinator, a podologist, a dedicated vascular interventional specialist, a foot surgical specialist, and an infectious disease specialist. Other specialists, like the cardiologist, the nephrologist, and the orthopedic surgeon should be involved whenever necessary.20,21 In Table 2, the Texas University Score matrix has been divided according to the 3-level organization of care for each level of severity of the DF. The 3-level model implies that between the different levels exists an active interaction and that cases should be referred and shared both ascending and descending in the complexity hierarchy, to select the cases that best fit with the different levels of care: The first-level centers should not manage complex cases and the third-level centers should not waste time and resources on simple cases. Thus, communication and coordination between the centers is crucial: The center of the same network should share the same treatment protocol, and share not only the cases but also the outcomes, and should check their results periodically, both in terms of efficiency and efficacy, as a quality assessment procedure and compare them with national and international referrals. Audits should be performed and corrective measures should be adopted in case the results diverge more than 20% from the expected. All the component of the team at each level of the chain of centers should participate to a meeting twice in a year during which results are presented and comments are elicited and future plans are decided. An independent external auditor would be of great help in managing the quality-related aspects in order to subtract this evaluation process to the personalization and to increase the objectification of results; sharing the databases of the centers should be the first step in this direction.

A Team Approach: The Most Difficult Task The term team is often wrongly used, applied to a number of different situation that does not fit with the definition of the concept. A group by itself does not necessarily constitute a team. A team actually comprises a group of people

linked in a common purpose. Teams are especially appropriate for conducting tasks that are high in complexity and have many interdependent subtasks. Teams normally have members with complementary skills and generate synergy through a coordinated effort which allows each member to maximize his or her strengths and minimize his or her weaknesses. A team becomes more than just a collection of people when a strong sense of mutual commitment creates synergy, thus generating performance greater than the sum of the performance of its individual members.22 Team members need to learn how to help one another, help other team members realize their true potential, and create an environment that allows everyone to go beyond their limitations.23 Applying these concepts to our field means to reflect on how all the professionals involved in the DF care should be part of a common project that should be shared and subscribed in any phase and at each level. The so-called “team-building process” should be part of the strategy to implement the DF care organization in order to obtain better outcomes and figures. The project to which the DF team is committed should be discussed and approved by all the professionals who should agree on basic principles and evaluations, keeping the responsibility of giving their own contribution in their specific area of competence, but agreeing on the general criteria for the other aspects (Figure 3). Guidelines and indicators are useful tools to extent the consensus on the project among the team members24; in Table 3, an algorithm for the decision making in patients with ischemic DF after the revascularization is reported as an example.25 The team leader should be recognized as such by all the members of the team and should be a figure with experience, authority, and mastery in order to be able to interact with the other member of the team without creating conflicts and possibly being able to solve critical situations. Although not mandatory, it would be desirable that the team leader in DF would be a diabetologist, both because DF is a chronic complication of diabetes mellitus strongly related and influenced by the underlying pathology, and because the internal medicine formation of the diabetologist

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Figure 3.  The Pisa Protocol for the management of the critically ischemic diabetic foot. From Scatena et al.20

Table 3.  Decisional Grid for Diabetic Patients with CLI Who Underwent Revascularization. Outcome Successful Consider a re-PTA Consider amputation

ΔTcPo2 (mm Hg)

Wound Area

ΔT (°C)

Cyanosis/Necrosisa

Paina

>30 30-10 3 3-1

Do you want to organize a multidisciplinary diabetic foot clinic? We can help.

The diabetic foot (DF) is a complex pathology involving the lower limb of 8 to 10 million people around the world, and its prevalence is rising, creat...
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