DIABETIC FOOT ULCER CLASSIFICATION SYSTEMS. A Review of the Literature

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A Review of the Literature Red Yellow Black (RYB) Breakdown (prominent in nursing literature) For this classification I didn t manage to find further information (yet) R: red wounds that exhibit pale pink to beefy red granulation tissue. Deemed to be inflammatory Y: yellow wounds marked by pale ivory, yellowish green or brown color, slough of necrotic but moist tissue, wound exudates B: black wounds marked by black or deep brown color, desiccated eschar Enna et al (1976) (2) Enna et al described four categories of non-ulcerated insensitive feet. Category 1: includes subjects lacking only sensation on the plantar aspect Category 2: includes those suffering from a loss of sensation and deficiency of the subcutaneous soft tissue Category 3: is defined as loss of plantar protective threshold, deficiency of plantar soft tissue, and gross deformity Category 4: includes the deformed, rigid, short foot secondary to distal osseous disintegration or ablative surgery Based on these categories, recommendations were made as to appropriate shoe accommodation (2) Meggitt-Wagner or just Wagner (19) (22) Meggitt (1975)/Wagner (1981) Grade 0: No open lesion but may have deformity or callus Grade 1: Superficial ulcer, partial or full-thickness Page 1 of 14

Grade 2: Ulcer extends to ligament, tendon, joint capsule or deep fascia without abscess or osteomyelitis Grade 3: Deep ulcer with abscess, osteomyelitis or joint sepsis Grade 4: Gangrene localized to forefoot or heel Grade 5: Extensive Gangrene While the Wagner classification is a simple, easy to remember system, based upon the location and depth of ulcerations, one should be aware of the system s limitations. The Wagner classification does not take the presence of neuropathy or the size of the lesion into account. (9) A validation of Wagner in relation to science, clinometric, readability, accuracy, reliability and validity has been published in 2008 (14) Stess and Hetherington (1989) (2) This system divides patients into three categories Category 1: includes the patient with lack of protective threshold, but with no ulcer and no active bony destruction Category 2: includes patients in whom active bone destruction is occurring Category 3: comprises ulcerated patients with or without bony deformity Ulcers in this system are subdivided as fundamental or complicated. This classification system does not address vascular insufficiency, nor does it take into account presence or absence of infection (2) Ulbrecht et al (1993) (2) This risk assessment system, designed to assist in predicting probability of plantar pedal ulceration in the neuropathic patient, is unique in its schematic structure. It incorporates four variables: Variable 1: foot deformity Variable 2: step loading time Page 2 of 14

Variable 3: footwear cushioning Variable 4: activity level By plotting the various factors on a graph, an assessment is made as to the potential foot-risk level. This innovative format provides an excellent framework for forming a logical, organized, treatment-oriented thought process. However, the format used in this system is too subjective to be reproducible on a wide level. Additionally, the present scheme does not include vascular status or infection in its assessment (2) Depth-Ischemia Classification of Diabetic Foot Lesions (10) - Brodsky (1993) The depth-ischemia classification is a modification of the Meggitt-Wagner to make it more rational and easier to use. Depth Classification Grade 0: At risk foot, previous ulcer or neuropathy with deformity that may cause new ulceration Grade 1: Superficial ulceration, not infected Grade 2: Deep ulceration exposing a tendon or joint (with or without superficial infection) Grade 3: Extensive ulceration with exposed bone and/or deep infection (i.e. osteomyelitis or abscess) Ischemia Classification Grade A: Not ischemic Grade B: Ischemic without gangrene Grade C: Partial (forefoot or heel gangrene of the foot Grade D: Complete foot gangrene Birke and Sims (1995) (2) Divided into four categories: Page 3 of 14 Category 0: Protective sensation intact

Category 1: loss of protective sensation Category 2: loss of protective sensation with high pressure on the plantar aspect or poor vascularity Category 3: including those with a history of ulcer or neuropathic fracture with major deformity This system is easy to use. The authors also make logical shoe recommendations based on foot risk. This classification system does not, however, include infection. In addition, it does not allow for vascular insufficiency to coexist with a previous history of ulceration. As was the intention of the authors, this index is an excellent tool for screening, but may not be as valuable for active or acute conditions, such as open ulceration or acute neuropathic Osteoarthropathy (2) Treatment-based Diabetic Foot Index Armstrong (1996) (2) More details on each category can be found in tables of the original article (2) Category 0: Minimal Pathology Category 1: Insensate Foot Category 2: Insensate Foot with Deformity Category 3: Demonstrated Pathology Category 4: Insensate Injury Category 4 A: Neuropathic Ulceration Category 4 B: Acute Charcot s Arthropathy Category 5: Infected Diabetic Foot Category 6: Dysvascular Foot Ideally, such a system would be used by all participants in the limb-salvage team. Clearly, the classification system reviewed calls for further validation through clinical investigation (2) Page 4 of 14

University of Texas Wound Classification System (UT) (20) (1996) While the Wagner classification shows 6 grades (0-5), the TU makes do with four grades (0-3) but has also four stages with each grade. So it ends up with 16 different categories. Stage A: No infection or ischemia Stage B: Infection present Stage C: Ischemia present Stage D: Infection and Ischemia present Grade 0: Epithelialized wound Grade 1: Superficial wound Grade 2: Wound penetrates to tendon or capsule Grade 3: Wound penetrates to bone or joint Armstrong tried to prove in a study (3) that outcomes deteriorated with increasing grade and stage of wounds when measured using the TU. Most classification systems previously reported in the medical literature have primarily focused on the depth of the ulceration and have neglected or inconsistently included infection and peripheral arterial occlusive disease (3) Oyibo et al (4) compared the Wagner and the TU in 2001. They stated that both systems are easy to use among health care providers, and both can provide a guide to planning treatment strategies. The conclusion of their study stated that the UT system s inclusion of stage makes it a better predictor of outcome. In Brazil a group of physicians compared the Wagner, the UT and the S(AD)SAD classification (17) IWGDF Risk Classification (14) (2001) This is a modified version of the Texas Foot Risk Classification: Group 0: No PN, no PAOD Group 1: PN, no PAOD, no deformity Group 2A: PN and deformity, no PAOD Page 5 of 14

Group 2B: POAD Group 3A: Ulcer history Group 3B: Amputation history Scottish Care Information Diabetes Collaboration (SCI-DC) (13) ulcer risk score (2001) Based on assess foot pulse, monofilament sensation, history of foot ulcer, presence of foot deformity and inability to self care, the SCI-DC categorizes: Low Risk: o Able to detect at least one pulse per foot AND o Able to feel 10g monofilament AND o No foot deformity, physical or visual impairment No previous ulcer Moderate Risk: o Unable to detect both pulse in a foot OR o Unable to feel 10g monofilament OR o Foot deformity OR o Unable to see or reach foot No history of previous ulcer High Risk: o Previous ulceration or amputation OR o Absent pulse AND unable to feel 10g monofilament OR o One of above with callus or deformity PEDIS (23) (2003) Page 6 of 14

Data extracted from the 2011 Interactive DVD International Consensus on the Diabetic Foot & Practical and Specific Guidelines on the Management and Prevention of the Diabetic Foot by the IWGDF 2011. See reference (23) for further details P (perfusion) Grade 1: No symptoms or signs of PAD in the affected foot Grade 2: Symptoms or signs of PAD, but not of critical limb ischemia Grade 3: Critical limb ischemia E (extent/size) Grade 1: Superficial full thickness ulcer, not penetrating D (depth of any structure deeper than the dermis tissue loss) Grade 2: Deep ulcer, penetrating below the dermis to subcutaneous structures, involving fascia, muscle, or tendon Grade 3: All subsequent layers of the foot involved, including bone and/or joint I (infection) Grade 1: No symptoms or signs of infection Grade 2: Infection involving the skin and the subcutaneous tissue only Grade 3: Erythema >2cm or infection involving structures deeper than the skin and subcutaneous tissues Grade 4: any foot infection with signs of systemic inflammatory response syndrome (SIRS) S (sensation) Grade 1: No loss of sensation Grade 2: Loss of sensation DEPA Score (2004) (9) Although the DEPA Scoring System is a validated system, it involved a small number of patients and a relatively short follow-up period D: depth of the ulcer E: extent of bacterial colonization P: phase of ulcer A: associated etiology If you check the reference in detail it seems to be too complicated to me. Page 7 of 14

Diabetic Foot Infection Guidelines (DFIG) (11) Infectious Disease Society of America (IDSA) (2004) Category 1, Uninfected: wound without purulence or any manifestation of inflammation Category 2, Mild: Manifestation of inflammation Category 3, Moderate: Infection in a patient who is systemically well and metabolically stable Category 4, Severe: Infection in a patient with systemic toxicity or metabolic instability S(AD)SAD (9) (12) (17) (2004) Developed by an English group. Each category does have three grades S(AD): Size (area, depth) Area: 0=Skin intact 1=Lesion < 1cm² 2=Lesion from 1 to 3cm² 3=Lesion > 3cm² Deep: 0=Skin intact 1=Superficial 2=Lesion penetration to tendon, periosteum, capsule 3=Lesion in bone or joint space S: Sepsis 0=./. 1=No infected lesions 2=Cellulitis-associated lesions 3=Lesions with osteomyelitis A: Arteriopathy 0=Pedal pulses present 1=Pedal pulses reduced or one missing 2=Absence of both pedal pulses 3=Gangrene D: Denervation 0=Intact 1=Reduced 2=Absent 3=Charcot joint Page 8 of 14

Diabetic Ulcer Severity Score (DUSS) (7) Beckert (2006) Becket et al categorized diabetic foot ulcer according to a severity score ranging from 0-4 using wound-based parameters Palpable Pedal Pulse Score: present = 0 / absent = 1 Probing to Bone Score: probing no = 0 / probing yes = 1 Ulcer Location (Toe or Foot) Score: toe = 0 / foot = 1 Presence of Multiple Ulcers Score: single = 0 / multiple = 1 Diabetic Ulcer Severity Score (DUSS) was calculated by adding these separate grading to a theoretical maximum of 4. (7) SINBAD Ince (2008) (18) Site 0=Forefoot 1=Midfoot and Hind Foot Ischemia 0=Pedal blood flow intact 1=Reduced pedal blood flow Neuropathy 0=Sensation intact 1=Sensation lost Infection 0=None (bacterial) 1=Present Area 0=Ulcer< 1cm² 1=Ulcer> 1cm² Depth 0=Ulcer confined to skin and subcutaneous tissue 1=Ulcer reaching muscle, tendon or deeper Risk Classification of the Foot Care Interest Group of ADA (19) (20) (2008) Risk Category 0: No LOPS, no PAD, no deformity Risk Category 1: LOPS +/- deformity Risk Category 2: PAD +/- LOPS Page 9 of 14 Risk Category 3: History of ulcer or amputation

KOBE Classification (21) (2010) Type I: Mainly PN Type II: Mainly PAD Type III: Mainly Infection Type IV: PN & PAD & infection In the cited article there are also treatment recommendations to each type. Simplistic Classification by Frykberg (2011) (1) Neuropathic Ischemic Neuroischemic Jain Teaching Tool (2012) Please see reference (24) This article is interesting as it was published in 2012(!) by an Indian surgeon from Bangalore (!) Van Acker/Peter Classification (VA/P) (16) This system is based on Wagner and UT (plus some other) and divides into 25(!) different classes on a two-dimensional axis. Unfortunately I couldn t find any further information, not even the year of first publication than the citied source (16) Comment: The summary is based on the articles I reviewed in a chronological order. Depending on the publication date, the information might be timely overlapping. I tried to assort the results based on the publication dates Page 10 of 14

Having reviewed the literature, you will notice that older articles mostly refer to Wagner and TU, several article offer comparison studies about the outcome related to the classification. I think we should not only concentrate on Wagner and TU. Although some classification systems are too simple and some are simply widely unknown in the physicians community, we must consider having a look at the upcoming, new classification systems, too. Especially the S(AD)SAD (17) seems to be interesting as it takes the dimension of the wound under consideration. These newer classification systems anyway still need to establish themselves in the physicians world. Further Reading for Understanding the Diabetic Foot: Beside several available books on Diabetic Foot (see attached list) and the very end of this summary, there are two further recommendations of mine to read: The Standard of Care for Evaluation and Treatment of Diabetic Foot Ulcers by: University of Michigan 2010, 26 pages, incl. an self-assessment examination This was a self-study brochure, certified to get CME points. Unfortunately expiration date was January 30 th, 2012 Diabetic Foot Disorders A clinical practice guideline by: Frykberg, R. / Zgonis, Th. / Armstrong, D. et al 2006 (revision) This was a supplement to The Journal of Foot & Ankle Surgery. The first edition published in 2000 Acronyms: CFU DFU LOPS PAD PAOD Chronic Foot Ulcer Diabetic Foot Ulcer Loss of Protective Sensation Peripheral Arterial Disease Peripheral Arterial Occlusive Disease Page 11 of 14

PN Peripheral Neuropathy References (1) Classifying Diabetic Foot Frykberg 2011 (2) Treatment-based Classification System for Assessment and Care of Diabetic Feet Armstrong 1996 (3) Validation of a Diabetic Wound Classification System Armstrong 1998 (4) A Comparison of Two Diabetic Foot Ulcer Classification Systems Oyibo et al 2001 (5) Diabetic Foot Ulcers Jeffcoate 2003 (6) Can a Diabetic Foot surgery Classification System Help Predict Complications? McCurdy 2006 (7) A New Wound-Based Severity Score for Diabetic Foot Ulcers Beckert et al 2006 (8) Wound Classification Systems: Are they Significantly Utilized in Practice? Hall 2006 (9) A Guide To Understanding the Various Wound Classification Systems Satterfield 2006 (10) Levin and O Neal s The Diabetic Foot, 7 th Ed. 2008 Chapter 8, Evaluation Techniques, page 223 (11) Validation of the Infectious Disease Society of America s Diabetic Foot Infection Classification System Lavery 2007 (12) Rate of healing of Neuropathic Ulcers of the foot in diabetes and its relationship to ulcer duration and ulcer area 2007 Ince (13) Scottish Foot Ulcer Risk Score Predicts Foot Ulcer Healing in a Regional Specialist Foot Clinic (14) Reevaluating the Way we Classify the Diabetic Foot Lavery 2008 (15) Validation of Wagner s Classification: A Literature Review Smith 2008 Page 12 of 14

(16) The Choice of Diabetic Foot Ulcer Classification in Relation to the final Outcome van Acker 2008 (17) Comparison of three systems of classification in predicting the outcome of diabetic foot ulcers in a Brazilian population Parisi 2008 (18) Use of the SINBAD Classification System and Score in Comparing Outcome of Foot Ulcer Management on Three Continents Ince 2008 (19) Comprehensive Foot Examination and Risk Assessment - Boulton - 2008 (20) A Review of the Pathophysiology, Classification, and Treatment of Foot Ulcers in Diabetic Patients Clayton 2009 (21) Total Management of Diabetic Foot Ulceration s Kobe Classification as a New Classification of Diabetic Foot Wounds Terashi 2010 (22) Evaluation of the diabetic foot according to Wagner s classification in a rural teaching hospital Akther 2011 (23) Diabetic foot ulcer classification system for research purpose IWGDF 2003 (24) A New Classification of Diabetic Foot Complications Jain - 2012 Literature The Foot in Diabetes 2nd Ed. Boulton, A. / Connor, H. / Cavanagh, P. 1994, 252 pages Wiley 0-471-94259-6 Das Diabetische Fuss-Syndrom Eine praxisorientierte Einführung Reike, H. 1993, 186 pages SMV 3-927290-25-4 Das diabetische Fußsyndrom Haslbeck, M. / Renner, R. / Berkau, H.-D. 2003, / 78 pages Medizin & Wissen 3-89935-197-5 Understanding Diabetic Foot Principles and management Sen, S.K. / Patnaik, G. 2012, 75 pages Page 13 of 14

Lambert Academic Publishing 3-8484-4296-6 Der diabetische Fuß Hepp, W. 1996, 195 pages, 107 pictures Blackwell 3-89412-249-8 Der diabetische Fuß 3.Aufl. Diagnose, Therapie und schuhtechnische Versorgung Bischof, F. / Meyerhoff, C. / Eltze, J. / Türk, K. 2007,143 pages C. Maurer 3-87517-018-0 The Diabetic Foot Medical and Surgical Management Veves, A. / Giurini, J. M. / LoGerfo, F.W. 2002, 475 pages Humana Press 0-89603-925-0 Atlas of the Diabetic Foot 2nd ed. Katsilambros, N. et al 2010, 249 pages Wiley-Blackwell 1-4051-9179-1 A Practical Manual of Diabetic Foot Care 2nd Ed. Edmonds, M. / Foster, A. / Sanders, L. 2008, 284 pages Blackwell 1-4051-6147-3 The Diabetic Foot 5th Ed. Levine, M. / O'Neal, L. / Bowker, J. 1993, 633 pages Mosby 0-8016-6878-6 The Diabetic Foot 7th Ed. Bowker, J. / Pfeifer, M. 2008, 627 pages Mosby 0-323-04145-4 Responsible for the content DARCO (Europe) GmbH Raphael Boehm, Vice President DARCO Europe Gewerbegebiet 18 82399 Raisting Germany Tel. +49 (0) 88 07.92 28-0 Fax +49 (0) 88 07.92 28-22 info@darco-europe.com www.darco-europe.com Page 14 of 14