Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP, et al.
Advances in skin & wound care. Date of publication 2005 Jun 1;volume 18(5 Pt 1):258-66.
1. Adv Skin Wound Care. 2005 Jun;18(5 Pt 1):258-66.
Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for
diabetic ulcers.
Niezgoda JA(1), Van Gils CC, Frykberg RG, Hodde JP.
Author information:
(1)Center for Comprehensive Wound Care and Hyperbaric Oxygen Therapy, St. Luke's
Medical Center, Milwaukee, WI, USA.
Comment in
Adv Skin Wound Care. 2006 Mar;19(2):64; author reply 64, 67.
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.
PMID: 15942317 [Indexed for MEDLINE]
