Diabetic Foot UlcerNCT04918784

Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers

A study testing Restrata® and Wound Dressing in people with Diabetic Foot Ulcer, run by Acera Surgical, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcer
What is being tested?: Restrata® and Wound Dressing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 5 May 2021to 1 Dec 2022
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

Patient is at least 18 years old
Patient is willing and capable of complying with all protocol requirements
Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period
Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
Ulcer must be located at least in part on the foot or ankle
Ulcer must be present for a minimum of 28 days prior to randomization and initial application of study product

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Wound size must be < 30cm2 on the day of randomization and initial application of the study product, after initial debridement
Patient has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following within 60 days prior to enrollment/randomization:
Dorsum transcutaneous oxygen test (TcPO2) of study leg with results ≥40mmHg, OR
Ankle-Brachial Index (ABI) of study leg with results of ≥ 0.7
Toe-Brachial Index (TBI) of study extremity with results of > 50 mmHg

Who cannot join

Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
Patient is pregnant, breast feeding or planning to become pregnant
Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
Patient has a life expectancy less than six months as assessed by the investigator
Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period
Patient has an additional wound within 3 cm of the study wound

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Hgb A1c > 12% within 3 months prior to randomization in patients with a known history of diabetes
Patient not in reasonable metabolic control in the judgment of the investigator
Patient with a known history of poor compliance with medical treatments
Patient currently undergoing cancer treatment
Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in 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 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
Patient unwilling to or unable to safely utilize appropriate offloading device to unweight wound
Study ulcer spontaneously closes during the 2-week run in period

Trial locations and contacts

1 site in 1 country.

United States1 site

Midwest Foot and Ankle Clinics
Hoffman Estates, Illinois, 60169

Other trials in United States

About this study

Official title: Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcer

Conditions: Diabetic Foot Ulcer
Being tested: Restrata®, Wound Dressing
Keywords: Synthetic Hybrid-Scale Fiber Matrix, Diabetic Foot Ulcer, Epithelialization
Medical subject headings: Diabetic Foot

What participants receive

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

Restrata®Device
Also called Synthetic Hybrid-Scale Fiber Matrix
Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
Wound DressingDevice
Alginate or Foam wound dressing is intended to manage wounds.

Study groups in NCT04918784
Study group	Role	What they receive
Treatment with Synthetic Hybrid-Scale Fiber Matrix	Experimental	Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment. Receives: Device: Restrata®
Treatment with Standard of Care	Active comparator	Diabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily. Receives: Device: Wound Dressing

What is being measured

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

Number of Participants With 100% Re-epithelialization
Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging.
Measured: 12 weeks

Secondary outcomes (3)

Change in Wound Area
The difference in wound area from baseline to 100% re-epithelialization or week 12 will be summarized for each treatment group in each arm. Wound sizes were documented by the investigator at baseline to end of the treatment period for each participant.
Measured: 12 weeks
Time to Wound Closure
The number of weeks from initial application of study treatment until complete re-epithelialization is first identified.
Measured: Up to 12 Weeks
Number of Treatment Applications
The number of study treatment applications including the initial application until 12 weeks or until complete re-epithelialization, whichever occurs first.
Measured: 12 weeks

Timeline

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

5 May 20211 Dec 2022

First posted9 Jun 2021
Study start5 May 2021
Primary completion31 Jul 2022
Study completion1 Dec 2022

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: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04918784
Sponsor's protocol ID: 21-RES-002
Status last verified: Sep 2023
First submitted: 12 May 2021
Last updated: 28 Sep 2023
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 28 Sep 2023. 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 Ulcer
ClinicalTrials.gov ID: NCT04918784
Acronym / sponsor ID: 21-RES-002
Conditions: Diabetic Foot Ulcer
Keywords: Synthetic Hybrid-Scale Fiber Matrix, Diabetic Foot Ulcer, Epithelialization
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Acera Surgical, Inc.Industry (pharma, biotech, devices)
Study start: 5 May 2021 (actual)
Primary completion: 31 Jul 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 9 Jun 2021 (actual)
Results: Posted 21 Sep 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Treatment with Synthetic Hybrid-Scale Fiber Matrix	Experimental	Device: Restrata®Diabetic foot ulcers will be treated by application of the Synthetic Hybrid-Scale Fiber Matrix. The synthetic matrix will be applied weekly or as needed based on the clinician discretion and ongoing wound assessment.
Treatment with Standard of Care	Active comparator	Device: Wound DressingDiabetic foot ulcers will be treated by application of an appropriate dressing (foam or alginate dressing) to maintain wound moisture balance in the wound and changed daily.

Who may qualify

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

Key inclusion criteria (11 listed)

Patient is at least 18 years old
Patient is willing and capable of complying with all protocol requirements
Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to or at the beginning of the run-in period
Patient has Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)
Ulcer must be located at least in part on the foot or ankle

Key exclusion criteria (16 listed)

Patient has been previously enrolled into this study, or is currently participating in another drug or device study that has not reached its primary endpoint
Patient is pregnant, breast feeding or planning to become pregnant
Patient has a known allergy to resorbable suture materials, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
Patient has a life expectancy less than six months as assessed by the investigator
Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period

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
Restrata®Also: Synthetic Hybrid-Scale Fiber MatrixRestrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.	Device	Treatment with Synthetic Hybrid-Scale Fiber Matrix
Wound DressingAlginate or Foam wound dressing is intended to manage wounds.	Device	Treatment with Standard of Care

Primary outcome

Number of Participants With 100% Re-epithelialization
Time frame: 12 weeks
Primary outcome is number of participants with 100% epithelialization at 12 weeks of treatment as determined by investigator assessment of the ulcer and imaging.

3 secondary outcomes

Change in Wound Area
Time frame: 12 weeks
Time to Wound Closure
Time frame: Up to 12 Weeks
Number of Treatment Applications
Time frame: 12 weeks

Results and safety

Results posted to the registry on 21 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With Synthetic Hybrid-Scale Fiber Matrix	25	19
Treatment With Standard of Care	21	18

Primary outcome: Number of Participants With 100% Re-epithelialization

Time frame: 12 weeks. Count of participants. Unit: Participants

Measure	Treatment With Synthetic Hybrid-Scale Fiber Matrix n = 19	Treatment With Standard of Care n = 18
Value	14	6

Population analysed: Patients who completed 12 weeks of treatment

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: For each individual patient, data was collected over the 12 week treatment period or until complete re-epithelialization and 2 week follow up visit, up to a maximum of 14 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With Synthetic Hybrid-Scale Fiber Matrix	2 of 25 (8%)	6 of 25 (24%)	1 of 25
Treatment With Standard of Care	2 of 21 (9.5%)	2 of 21 (9.5%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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.

Khalid Husain, DPM principal investigator

Midwest Foot & Ankle Clinics

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

Questions about this trial

What is this clinical trial studying?

A study testing Restrata® and Wound Dressing in people with Diabetic Foot Ulcer, run by Acera Surgical, Inc. at 1 site in United States.

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 11 inclusion and 16 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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 21 Sep 2023). 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?

Number of Participants With 100% Re-epithelialization (time frame: 12 weeks). 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 NCT04918784.

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 28 Sep 2023.