Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
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®)
• 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:
‣ Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥40mmHg, OR
⁃ Ankle-Brachial Index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.3, OR
⁃ Toe-Brachial Index (TBI) of study extremity(ies) with results of ≥ 0.5
• 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:
‣ Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥ 40mmHg, OR
⁃ Ankle-brachial index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.52, OR
⁃ Toe-Brachial Index (TBI) of study leg(s) with results of ≥ 0.5, OR
⁃ Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected leg(s)