In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care. In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
47
A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended.
An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
ILD Research Center
Vista, California, United States
University of Florida - Jacksonville
Jacksonville, Florida, United States
Barry University
Miami Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
Gundersen Health System
La Crosse, Wisconsin, United States
For Participants With Diabetic Foot Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound
100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
Time frame: 12 weeks
For Participants With Venous Leg Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound
100 percent epithelialization of wound as assessed by a blinded evaluator via review of a three-dimensional high resolution photo of the wound plus confirmation of no drainage or need for additional dressing 2 weeks after 100 percent epithelialization
Time frame: 16 weeks
Decrease in Wound Area
Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements.
Time frame: Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.
Time to 100 Percent Epithelialization
The number of weeks from initial application of study product until 100 percent epithelialization is first identified.
Time frame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.
Number of Product Applications
The number of applications of study product until 100 percent epithelialization is first identified
Time frame: 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first
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