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Aristidis Veves, MD; Peter Sheehan, MD; Hau T. Pham, DPM; for the Promogran Diabetic Foot Ulcer Study

Arch Surg. 2002;137:822-827.

Hypothesis  Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers.

Design  Randomized, prospective, controlled multicenter trial.

Setting  University teaching hospitals and primary care centers.

Patients  A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer.

Interventions  Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks.

Main Outcome Measure  Complete healing of the study ulcer (wound).

Results  After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P = .12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P = .056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P = .83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze.

Conclusions  Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.

From the Joslin Beth Israel Deaconess Foot Center, Boston, Mass (Drs Veves and Pham), and the Diabetes Foot and Ankle Center, Hospital for Joint Diseases Orthopaedic Institute, New York, NY (Dr Sheehan).

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