Related Experiment Video
Updated: Aug 17, 2026
Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers
Jeffrey A Niezgoda1, Carl C Van Gils, Robert G Frykberg
1Center for Comprehensive Wound Care and Hyperbaric Oxygen Therapy, St. Luke's Medical Center, Milwaukee, WI, USA.
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.
