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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®)
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Inclusion and exclusion criteria
Inclusion Criteria for Participants with Diabetic Foot Ulcers:
Participant is at least 18 years old
Participant is willing and capable of complying with all protocol requirements
Participant or legally authorized representative (LAR) is willing to provide written informed consent
Participant has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
Ulcer(s) must be located at least in part on the foot or ankle
Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy
Wound size must be >1.0 cm^2 and < 25 cm^2 on the day of randomization and initial application of the study product, after initial debridement
Participant has adequate circulation to the affected extremity(ies), as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
Exclusion Criteria for Participants with Diabetic Foot Ulcers:
Inclusion Criteria for Participants with Venous Leg Ulcers:
Participant is at least 18 years old
Participant is willing and capable of complying with all protocol requirements
Participant or legally authorized representative (LAR) is willing to provide written informed consent
Participant has peripheral venous disease per investigator judgment or diagnostic confirmation
Ulcer(s) must be venous in origin, located on a lower extremity
Ulcer(s) must be present for more than 28 days prior to randomization and initial application of study product, and has not adequately responded to conventional ulcer therapy
Wound(s) size must be >1.0 cm^2 and < 50 cm^2 on the day of randomization and initial application of the study product, after initial debridement
Participant has adequate circulation to the affected extremity(ies), as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
Exclusion Criteria for Participants with Venous Leg Ulcers:
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47 participants in 4 patient groups
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Chief Science Officer
Data sourced from clinicaltrials.gov
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