Driver VR, Lavery LA, Reyzelman AM, Dutra TG, Dove CR, Kotsis SV, Kim HM, Chung KC, et al.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the Eur.... Date of publication 2015 Nov 1;volume 23(6):891-900.
1. Wound Repair Regen. 2015 Nov-Dec;23(6):891-900. doi: 10.1111/wrr.12357. Epub 2015
Oct 19.
A clinical trial of Integra Template for diabetic foot ulcer treatment.
Driver VR(1), Lavery LA(2), Reyzelman AM(3), Dutra TG(4), Dove CR(5), Kotsis
SV(6), Kim HM(7), Chung KC(6).
Author information:
(1)Department of Orthopedic Surgery (Clinical), Brown University Alpert School of
Medicine, Providence, Rhode Island.
(2)Department of Plastic Surgery, University of Texas Southwestern, Dallas,
Texas.
(3)Department of Medicine, California School of Podiatric Medicine and UCSF
Center for Limb Preservation, California School of Podiatric Medicine at Samuel
Merritt University, Oakland, California.
(4)Applied Biomechanics, California School of Podiatric Medicine at Samuel
Merritt University, Oakland, California.
(5)Advanced Foot & Ankle Center, Las Vegas, Nevada.
(6)Section of Plastic Surgery, Department of Surgery, The University of Michigan
Medical School.
(7)Center for Statistical Consultation and Research, The University of Michigan,
Ann Arbor, Michigan.
Individuals with diabetes mellitus are at an increased risk of developing a
diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of
Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs.
The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized,
controlled, parallel group clinical trial conducted under an Investigational
Device Exemption. Thirty-two sites enrolled and randomized 307 subjects with at
least one DFU. Consented patients were entered into the 14-day run-in phase where
they were treated with the standard of care (0.9% sodium chloride gel) plus a
secondary dressing and an offloading/protective device. Patients with less than
30% reepithelialization of the study ulcer after the run-in phase were randomized
into the treatment phase. The subjects were randomized to the control treatment
group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT,
n = 154). The treatment phase was 16 weeks or until confirmation of complete
wound closure (100% reepithelialization of the wound surface), whichever occurred
first. Following the treatment phase, all subjects were followed for 12 weeks.
Complete DFU closure during the treatment phase was significantly greater with
IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks.
The median time to complete DFU closure was 43 days for IDRT subjects and 78 days
for control subjects in wounds that healed. The rate of wound size reduction was
7.2% per week for IDRT subjects vs. 4.8% per week for control subjects
(p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time
to complete wound closure, increased the rate of wound closure, improved
components of quality of life and had less adverse events compared with the
standard of care treatment. IDRT could greatly enhance the treatment of
nonhealing DFUs.
© 2015 by the Wound Healing Society.
DOI: 10.1111/wrr.12357
PMID: 26297933 [Indexed for MEDLINE]
