Diabetic Foot UlcerNCT03312595
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
A study testing Restrata TM Wound Matrix in people with Diabetic Foot Ulcer, run by Acera Surgical, Inc. at 5 sites in United States.
Trial summary
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Restrata TM Wound Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Sep 2017to 30 Jul 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age 18 or older
- Patient's ulcer must be diabetic in origin, located at least in part on the plantar surface and larger than 1cm2 after the run-in period. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two-week run in period will precede enrollment/randomization in the trial to document the indolent nature of the patients selected
- Patient does not exhibit clinical signs / symptoms of infection upon gross observation (at least 3 of the following: pain, redness, purulence, exudate, temperature) or have been diagnosed with an active infection at time of screening
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study
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- Patient has adequate control of diabetes, as demonstrated by one of the following within 30 days of screening:
- HbA1c < 12%
- Serum Creatinine < 3.0mg/dl
- Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days of the first screening visit:
- Dorsum transcutaneous oxygen test (TcPO2) with results
- ≥30mmHg, OR
- ABIs with results of ≥0.7 and ≤1.5, OR
- Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
Who cannot join
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D)
- Patients whose index diabetic foot ulcers are greater than 25cm2
- Patient has an additional wound within 3cm of the study wound
- Patients not in reasonable metabolic control
- Patients with a known history of poor compliance with medical treatments
- Patients who have been previously enrolled into this study, or are presently participating in a clinical trial with DFU indications
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- Patients with known or suspected local skin malignancy to the index diabetic ulcer
- Patients diagnosed with autoimmune connective tissues diseases
- Patients that have received a graft material on the study ulcer within the previous 30 days
- Patients who are pregnant or breast feeding
- Patients who are taking medications that are considered immune system modulator
- Study wound has closed > 30% over the two-week run-in period
- Patients with a known allergy to resorbable suture materials
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Richard C. Galperin, DPM
Dallas, Texas, 75208
Advanced Foot Care And Clinical Research Center
Fresno, California, 93722
Associated Foot & Ankle Specialists
Phoenix, Arizona, 85015
Arizona Reginal Medical Research
Tucson, Arizona, 85710
SAVAHCS
Tucson, Arizona, 85723
About this study
Official title: Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).
Read the detailed description
Control Group: None (Utilize historical / published data on outcomes using standard of care)
Test Group: Treatment of DFUs with RestrataTM Wound Matrix
Study Type: Interventional
Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Restrata TM Wound Matrix
- 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 TM Wound MatrixDevice
The RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds
| Study group | Role | What they receive |
|---|---|---|
| Restrata TM Wound Matrix | Other | Prospective, single armed, non-randomized study with direct assignment Receives: Device: Restrata TM Wound Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Wound Closed
from baseline at week 0 to 14 weeks
Measured: Up to 14 weeks
Secondary outcomes (2)
Change in Wound Area From Baseline
Wound area measurements will be made via tracing acetate every week for 14 weeks.
Measured: Baseline and weekly for up to 14 weeks
Time to Wound Closure
The number of weeks until complete closure is first identified will be determined for each patient who has been deemed completely closed within the 14 week treatment period.
Measured: Baseline up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start14 Sep 2017
- Primary completion15 Jul 2018
- Study completion30 Jul 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acera Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312595
- Sponsor's protocol ID
- 17-RES-001
- Status last verified
- Aug 2025
- First submitted
- 1 Oct 2017
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures
- ClinicalTrials.gov ID
- NCT03312595
- Acronym / sponsor ID
- 17-RES-001
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acera Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Posted 26 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).
Detailed description
Control Group: None (Utilize historical / published data on outcomes using standard of care)
Test Group: Treatment of DFUs with RestrataTM Wound Matrix
Study Type: Interventional
Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restrata TM Wound Matrix | Other | Device: Restrata TM Wound MatrixProspective, single armed, non-randomized study with direct assignment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female age 18 or older
- Patient's ulcer must be diabetic in origin, located at least in part on the plantar surface and larger than 1cm2 after the run-in period. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two-week run in period will precede enrollment/randomization in the trial to document the indolent nature of the patients selected
- Patient does not exhibit clinical signs / symptoms of infection upon gross observation (at least 3 of the following: pain, redness, purulence, exudate, temperature) or have been diagnosed with an active infection at time of screening
Key exclusion criteria (13 listed)
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D)
- Patients whose index diabetic foot ulcers are greater than 25cm2
- Patient has an additional wound within 3cm of the study wound
- Patients not in reasonable metabolic control
- Patients with a known history of poor compliance with medical treatments
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 TM Wound MatrixThe RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds | Device | Restrata TM Wound Matrix |
Primary outcome
Percentage of Participants With Wound Closed
Time frame: Up to 14 weeks
from baseline at week 0 to 14 weeks
2 secondary outcomes
Change in Wound Area From Baseline
Time frame: Baseline and weekly for up to 14 weeks
Time to Wound Closure
Time frame: Baseline up to 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrata TM Wound Matrix in people with Diabetic Foot Ulcer, run by Acera Surgical, Inc. at 5 sites 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 14 inclusion and 13 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 26 Apr 2021). 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?
Percentage of Participants With Wound Closed (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2025.