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


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


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


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Niezgoda
Jeffrey A
JA
Center for Comprehensive Wound Care and Hyperbaric Oxygen Therapy, St. Luke's Medical Center, Milwaukee, WI, USA.
Van Gils
Carl C
CC
Frykberg
Robert G
RG
Hodde
Jason P
JP
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000077214:Becaplermin; D001672:Biocompatible Materials / Q000627:therapeutic use*; D017719:Diabetic Foot / Q000188:drug therapy* / Q000517:prevention & control; D005109:Extracellular Matrix; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D010982:Platelet-Derived Growth Factor / Q000627:therapeutic use*; D011446:Prospective Studies; D020574:Proto-Oncogene Proteins c-sis; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
D001672:Biocompatible Materials; D005782:Gels; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D000077214:Becaplermin