Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers

Abstract

Objective: To compare healing rates at 12 weeks for full-thickness diabetic foot ulcers treated with OASIS Wound Matrix, an acellular wound care product, versus Regranex Gel.

Design: Randomized, prospective, controlled multicenter trial at 9 outpatient wound care clinics.

Subjects: A total of 73 patients with at least 1 diabetic foot ulcer were entered into the trial and completed the protocol.

Intervention: Patients were randomized to receive either OASIS Wound Matrix (n = 37) or Regranex Gel (n = 36) and a secondary dressing. Wounds were cleansed and debrided, if needed, at a weekly clinic visit. Dressings were changed as needed. The maximum treatment period for each patient was 12 weeks.

Primary outcome measure: Incidence of healing in each group at 12 weeks.

Results: After 12 weeks of treatment, 18 (49%) OASIS-treated patients had complete wound closure compared with 10 (28%) Regranex-treated patients.

Conclusion: Although the sample size was not large enough to demonstrate that the incidence of healing in the OASIS group was statistically superior (P = .055), the study results showed that treatment with OASIS is as effective as Regranex in healing full-thickness diabetic foot ulcers by 12 weeks.