A Randomized, Controlled Trial of Promogran (A collagen/oxidized Regenerated Cellulose Dressing) vs Standard Treatment in the Management of Diabetic Foot Ulcers

Arch Surg. 2002 Jul;137(7):822-7. doi: 10.1001/archsurg.137.7.822.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Bandages*
  • Cellulose, Oxidized / therapeutic use*
  • Collagen / therapeutic use*
  • Diabetic Foot / drug therapy
  • Diabetic Foot / therapy*
  • Female
  • Hemostatics / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Treatment Outcome
  • Wound Healing / drug effects*

Substances

  • Cellulose, Oxidized
  • Hemostatics
  • Collagen