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)

NATerminatedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

July 19, 2021

Primary Completion Date

July 15, 2024

Study Completion Date

August 1, 2024

Conditions
Diabetic Foot UlcerVenous Leg Ulcer
Interventions
DEVICE

Synthetic Hybrid-Scale Fiber Matrix

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.

DEVICE

Standard of Care

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.

DEVICE

Living Cellular Skin Substitute

An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.

Trial Locations (6)

32209

University of Florida - Jacksonville, Jacksonville

33169

Barry University, Miami Beach

54601

Gundersen Health System, La Crosse

60612

Rush University Medical Center, Chicago

92083

ILD Research Center, Vista

02118

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Acera Surgical, Inc.

INDUSTRY

NCT04927702 - 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) | Biotech Hunter | Biotech Hunter