Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures.

OBJECTIVE: The purpose of this study was to compare different outcome measures in the audit of management of diabetic foot ulcers RESEARCH DESIGN AND METHODS: Data collected prospectively in a consecutive cohort of patients referred to a specialist multidisciplinary foot care clinic between 1 January 2000 and 31 December 2003 were analyzed. A single index ulcer was selected for each patient and classified according to both the Size (Area and Depth), Sepsis, Arteriopathy, and Denervation [S(AD)SAD] and University of Texas (UT) systems. Ulcer-related outcomes (healing, resolution by ipsilateral amputation or by death, and persisting unhealed) were determined at 6 and 12 months and compared with patient-related outcomes (survival, any amputation, and being free from any ulcer) at 12 months. RESULTS: In 449 patients (63.7% male, mean age 66.7 +/- 13.2 years), 352 (78.4%) ulcers were superficial [S(AD)SAD/UT grade 1] and 134 of these (38.1% of 352) were neither ischemic nor infected. A total of 183 (40.8% of 449) ulcers were clinically infected, and peripheral arterial disease was present in 216 patients (48.1%). Seventeen patients (3.8%) were lost to follow-up and were excluded from analysis. Of the ulcers, 247 (55.0% of 449) and 295 (65.7%) healed without amputation by 6 and 12 months, respectively. Median (range) time to healing was 78 (7-364) days. Of all index ulcers, 5.8 and 8.0% were resolved by amputation, and 6.2 and 10.9% by death by the same time points; 27.8 and 11.6% persisted unhealed. In contrast, patient-related outcomes revealed that of 449 patients only 202 (45.0%) were alive, without amputation, and ulcer free at 12 months. This group had had 272 (1-358) days without any ulcer. A total of 48 (10.7%) patients had undergone some form of amputation, and 75 (16.7%) had died. CONCLUSIONS: These data illustrate the extent to which ulcer-related outcomes may underestimate the true morbidity and mortality associated with diabetic foot disease. It is suggested that when attempts are made to compare the effectiveness of management in different centers, greater emphasis should be placed on patient-related outcome measures.

Use of the SINBAD classification system and score in comparing outcome of foot ulcer management on three continents.

OBJECTIVE: To compare populations with and outcomes of diabetic foot ulcers managed in the U.K., Germany, Tanzania, and Pakistan and to explore the use of a new score of ulcer type in comparing outcomes among different countries. RESEARCH DESIGN AND METHODS: Data from a series of 449 patients with diabetic foot ulcers managed in the U.K. were used to evaluate the new simplified system of classification and to derive an aggregate score. The use of the score was then explored using data from series managed in Germany (n = 239), Tanzania (n = 479), and Pakistan (n = 173). RESULTS: A highly significant difference was found in time to healing between ulcers of increasing score in the U.K. series (Kruskal-Wallis test; P = 0). When data from all centers were examined, a step-up in days to healing was noted for those with scores of >or=3 (out of 6). Examination of baseline variables contributing to outcome revealed the following differences among centers: ischemia, ulcer area, and depth contributing to outcome in the U.K.; ischemia, area, depth, and infection in Germany; depth, infection, and neuropathy in Tanzania; and depth alone in Pakistan. CONCLUSIONS: Any system of classification designed for general implementation must encompass all the variables that contribute to outcome in different communities. Adoption of a simple score based on these variables, the Site, Ischemia, Neuropathy, Bacterial Infection, and Depth (SINBAD) score, may prove useful in predicting ulcer outcome and enabling comparison among different centers.

Rate of healing of neuropathic ulcers of the foot in diabetes and its relationship to ulcer duration and ulcer area.

OBJECTIVE: To examine the outcome of neuropathic foot ulcers and to seek associations between healing and features of the ulcers at baseline. RESEARCH DESIGN AND METHODS: Data were collected prospectively during the course of routine management. All patients were selected who presented to a single unit between 1 January 2000 and 31 December 2004 with neuropathic foot ulcers and without evidence of either peripheral arterial disease or infection. Associations were sought between ulcer characteristics at baseline and clinical outcome. RESULTS: A total of 154 patients (66.9% male) presented with 410 ulcers. Age was 57.4 +/- 12.0 years (means +/- SD). A total of 178 (43.4%) ulcers were on the plantar aspect of the foot; 73.7% of ulcers had a cross-sectional area of <1 cm2. Median ulcer duration at referral was 15 days (range 1-1,046). Healing without amputation was observed in 91.7%. The percentage of ulcers healed at 12, 20, and 52 weeks were 59.3, 70.5, and 86.6%, respectively. Significant associations were observed between area at referral and outcome type (chi2 P < 0.0001), prior ulcer duration (Kruskal-Wallis P = 0.006), and time to healing (Kruskal-Wallis P = 0.014), as well as between ulcer duration and time to healing (Spearman rho, r = 0.104, P = 0.047). There was no difference between plantar and nonplantar ulcers. CONCLUSIONS: The rate of healing in this cohort provides a benchmark for comparison with other centers. While further work is needed to determine how outcomes can be improved in unselected series such as these, the confirmation of close relationships between ulcer duration at referral, ulcer area, and outcome emphasizes the importance of early expert assessment of newly occurring neuropathic ulcers.