Diabetic Foot UlcerNCT04927702

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)

A study testing Synthetic Hybrid-Scale Fiber Matrix and Living Cellular Skin Substitute in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Acera Surgical, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcer, Venous Leg Ulcer
What is being tested?: Synthetic Hybrid-Scale Fiber Matrix and Living Cellular Skin Substitute
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 6 sitesUnited States
Study dates: 19 Jul 2021to 1 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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)

Who cannot join

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 known allergy to bovine materials or agarose shipping materials
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 the beginning of the screening period

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Participant has an additional wound within 3 cm of the study wound or study wounds are less than 3 cm apart
Hgb A1c > 12 percent within 3 months prior to randomization in patients with a known history of diabetes
Participant is not in reasonable metabolic control in the judgment of the investigator
Participant has 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
Participant unwilling or unable to tolerate use of compression therapy for the duration of the study
Study ulcer(s) experiences greater than 30 percent reduction over the 2-week run-in period
Participant also has a diabetic foot ulcer that is enrolled into this study

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Boston Medical Center
Boston, Massachusetts, 02118
Rush University Medical Center
Chicago, Illinois, 60612
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Gundersen Health System
La Crosse, Wisconsin, 54601
Barry University
Miami Beach, Florida, 33169
ILD Research Center
Vista, California, 92083

Other trials in United States

About this study

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: Diabetic Foot Ulcer, Venous Leg Ulcer
Being tested: Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
Medical subject headings: Diabetic Foot, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Synthetic Hybrid-Scale Fiber MatrixDevice
Also called Restrata
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.
Standard of CareDevice
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.
Living Cellular Skin SubstituteDevice
Also called Apligraf
An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.

Study groups in NCT04927702
Study group	Role	What they receive
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) Receives: 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) Receives: 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) Receives: 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) Receives: Device: Living Cellular Skin Substitute

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 16 weeks

Secondary outcomes (3)

Percentage Change in Wound Area
Wound area measurements will be made via a three-dimensional high resolution photo of the wound with automated measurements. Mean percent wound change will be calculated for each treatment arm/group with Week 1 as the baseline value. Change is calculated using the 2-week follow up visit after wound closure for wounds that achieved closure, or for wounds that did not achieve closure, the Week 12 wound area for DFUs and Week 16 wound area for VLUs.
Measured: 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
The number of weeks from initial application of study product until 100 percent epithelialization is first identified.
Measured: 12 weeks for DFU wounds (16 weeks for VLU wounds), or until 100 percent epithelialization, whichever occurs first.
Total Number of Product Applications
The number of study applications including the initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first
Measured: Initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 20211 Aug 2024

First posted16 Jun 2021
Study start19 Jul 2021
Primary completion15 Jul 2024
Study completion1 Aug 2024

Why it stopped: Study was terminated due to slow enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04927702
Sponsor's protocol ID: 21-RES-001
Status last verified: Feb 2026
First submitted: 3 Jun 2021
Last updated: 27 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04927702
Acronym / sponsor ID: 21-RES-001
Conditions: Diabetic Foot Ulcer, Venous Leg Ulcer
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated due to slow enrollment
Enrolment: 48 participants (actual)
Lead sponsor: Acera Surgical, Inc.Industry (pharma, biotech, devices)
Study start: 19 Jul 2021 (actual)
Primary completion: 15 Jul 2024 (actual)
Study completion: 1 Aug 2024 (actual)
First posted: 16 Jun 2021 (actual)
Results: Posted 27 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Experimental	Device: Synthetic Hybrid-Scale Fiber MatrixBiweekly (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	Active comparator	Device: Standard of CareWeekly application for either 12 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	Experimental	Device: Synthetic Hybrid-Scale Fiber MatrixBiweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	Active comparator	Device: Living Cellular Skin SubstituteBiweekly (every 2 weeks) application for either 16 weeks or until 100 percent epithelialization / wound closure (whichever occurs first)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (17 listed)

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 known allergy to bovine materials or agarose shipping materials
Participant has a life expectancy less than six months as assessed by the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Synthetic Hybrid-Scale Fiber MatrixAlso: RestrataA 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	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 CareTo 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	Diabetic Foot Ulcer Participants Assigned to Standard of Care
Living Cellular Skin SubstituteAlso: ApligrafAn absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.	Device	Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)

Primary outcome

For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
Time frame: 12 weeks
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
For Venous Leg Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound
Time frame: 16 weeks
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

3 secondary outcomes

Percentage Change in Wound Area
Time frame: 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
Time frame: 12 weeks for DFU wounds (16 weeks for VLU wounds), or until 100 percent epithelialization, whichever occurs first.
Total Number of Product Applications
Time frame: Initial application until 12 weeks for DFU patients and 16 weeks for VLU patients, or until 100% re-epithelialization, whichever occurs first

Results and safety

Results posted to the registry on 27 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	8	2
Diabetic Foot Ulcer Participants Assigned to Standard of Care	10	6
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	14	11
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	16	13

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

Time frame: 12 weeks. Count of units. Unit: wounds

Measure	Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®) n = 2	Diabetic Foot Ulcer Participants Assigned to Standard of Care n = 6
Value	2	1

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

Time frame: 16 weeks. Count of units. Unit: wounds

Measure	Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®) n = 11	Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®) n = 13
Value	1	4

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 weeks after healing OR 2 weeks after 12-14 weeks of treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diabetic Foot Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Diabetic Foot Ulcer Participants Assigned to Standard of Care	3 of 10 (30%)	4 of 10 (40%)	0 of 10
Venous Leg Ulcer Participants Assigned to Synthetic Hybrid-Scale Fiber Matrix (Restrata®)	1 of 14 (7.1%)	8 of 14 (57.1%)	0 of 14
Venous Leg Ulcer Participants Assigned to Living Cellular Skin Substitute (Apligraf®)	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetic Foot Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

For Diabetic Foot Ulcers, Number of Wounds With 100 Percent Epithelialization (Closure) of Wound (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04927702.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.