Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)

NCT03312595 | Completed Results FDA Device

• 1 other identifier: 17-RES-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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. 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).

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Wound Closed

  from baseline at week 0 to 14 weeks

  Up to 14 weeks

Secondary Outcomes (2)

• Change in Wound Area From Baseline

  Baseline and weekly for up to 14 weeks

• Time to Wound Closure

  Baseline up to 14 weeks

Study Arms (1)

Restrata TM Wound Matrix

OTHER

Prospective, single armed, non-randomized study with direct assignment

Device: Restrata TM Wound Matrix

Interventions

Restrata TM Wound Matrix DEVICE

The RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds

Restrata TM Wound Matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Acera Surgical, Inc.: lead

Study Sites (5)

Associated Foot & Ankle Specialists

Phoenix, Arizona, 85015, United States

Location

Arizona Reginal Medical Research

Tucson, Arizona, 85710, United States

Location

SAVAHCS

Tucson, Arizona, 85723, United States

Location

Advanced Foot Care And Clinical Research Center

Fresno, California, 93722, United States

Location

Richard C. Galperin, DPM

Dallas, Texas, 75208, United States

Location

MeSH Terms

Conditions

Diabetic Foot

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

Results Point of Contact

• Title: Chief Science Officer
• Organization: Acera Surgical, Inc.

information@acera-surgical.com

844-879-2237

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2017
• First Posted: October 18, 2017
• Study Start: September 14, 2017
• Primary Completion: July 15, 2018
• Study Completion: July 30, 2018
• Last Updated: September 16, 2025
• Results First Posted: April 26, 2021

Record last verified: 2025-08

Locations

US (5)