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)

NCT04927702 | Terminated Results FDA Device

• 1 other identifier: 21-RES-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

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®)

Conditions

Venous Leg Ulcer; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound

  The number of wounds in each treatment arm that achieved 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

  12 weeks

• For Venous Leg Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound

  The number of wounds in each treatment arm with 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

  16 weeks

Secondary Outcomes (3)

• Percentage Change in Wound Area

  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

  12 weeks for DFU wounds (16 weeks for VLU wounds), or until 100 percent epithelialization, whichever occurs first.

• Total Number of Product Applications

  Initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first

Study Arms (4)

Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)

EXPERIMENTAL

Biweekly (every 2 weeks) application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Device: Synthetic Hybrid-Scale Fiber Matrix

Diabetic Foot Ulcer Participants Assigned to Standard of Care

ACTIVE COMPARATOR

Weekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Device: Standard of Care

Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)

EXPERIMENTAL

Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Device: Synthetic Hybrid-Scale Fiber Matrix

Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)

ACTIVE COMPARATOR

Biweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Device: Living Cellular Skin Substitute

Interventions

Living Cellular Skin Substitute DEVICE

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

Also known as: Apligraf

Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)

Synthetic Hybrid-Scale Fiber Matrix DEVICE

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.

Also known as: Restrata

Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®); Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)

Standard of Care DEVICE

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.

Diabetic Foot Ulcer Participants Assigned to Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participant has been previously enrolled into this study, or is currently participating in another prospective drug or device study that has not reached its primary endpoint
• Participant is pregnant, breast feeding or planning to become pregnant
• Participant has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
• Participant has a life expectancy less than six months as assessed by the investigator
• Participant has received skin substitutes during the screening period or within 14 days prior to beginning of screening period
• Participant has an additional wound within 3 cm of the study wound(s) or study wounds are less than 3 cm apart
• Hgb A1c \> 12 percent within 3 months prior to randomization
• Participant not in reasonable metabolic control in the judgment of the investigator
• Participant with a known history of poor compliance with medical treatments
• Participant currently undergoing cancer treatment
• Participant has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
• Participant is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the screening period or up to 30 days before the screening period. Chronic oral steroid use is not excluded if dose is \< 10 mg per day for prednisone.
• Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator
• Osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence
• Participant unwilling or unable to safely utilize appropriate offloading device to unweight wound(s)

Sponsors & Collaborators

• Acera Surgical, Inc.: lead

Study Sites (6)

ILD Research Center

Vista, California, 92083, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Barry University

Miami Beach, Florida, 33169, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Matthew MacEwan
• Organization: Acera Surgical INC

macewan@acera-surgical.com

440-477-1890

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 16, 2021
• Study Start: July 19, 2021
• Primary Completion: July 15, 2024
• Study Completion: August 1, 2024
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)