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)

Not Applicable

Terminated

• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer
• Interventions: Device: Synthetic Hybrid-Scale Fiber Matrix; Device: Standard of Care; Device: Living Cellular Skin Substitute

• Registration Number: NCT04927702
• Lead Sponsor: Acera Surgical, Inc.

Brief Summary

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®)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Study Start: 2021-07-19
• Primary Completion: 2024-07-15
• Status Verified: 2024-08
• Study Completion: 2024-08-01
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Synthetic Hybrid-Scale Fiber Matrix	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Synthetic Hybrid-Scale Fiber Matrix	Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Diabetic Foot Ulcer Participants Assigned to Standard of Care	Standard of Care	Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	Living Cellular Skin Substitute	Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Primary Outcome Measures

Name	Time	Method
For Participants With Diabetic Foot Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound	12 weeks	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
For Participants With Venous Leg Ulcers, number of participants with 100 Percent Epithelialization (Closure) of Wound	16 weeks	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

Secondary Outcome Measures

Name	Time	Method
Decrease in Wound Area	Weekly assessments for 12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.	Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements.
Time to 100 Percent Epithelialization	12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first.	The number of weeks from initial application of study product until 100 percent epithelialization is first identified.
Number of Product Applications	12 weeks for DFU participants (16 weeks for VLU participants), or until 100 percent epithelialization, whichever occurs first	The number of applications of study product until 100 percent epithelialization is first identified

Trial Locations

Locations (6)

University of Florida - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Barry University; 🇺🇸 Miami Beach, Florida, United States

ILD Research Center; 🇺🇸 Vista, California, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Gundersen Health System; 🇺🇸 La Crosse, Wisconsin, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States