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

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).

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Restrata TM Wound Matrix

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Associated Foot & Ankle Specialists
    • Tucson, Arizona, United States, 85710
      • Arizona Reginal Medical Research
    • Tucson, Arizona, United States, 85723
      • SAVAHCS
  • California
    • Fresno, California, United States, 93722
      • Advanced Foot Care And Clinical Research Center
  • Texas
    • Dallas, Texas, United States, 75208
      • Richard C. Galperin, DPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Restrata TM Wound Matrix; Prospective, single armed, non-randomized study with direct assignment	Device: Restrata TM Wound Matrix; The RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Wound Closed	from baseline at week 0 to 14 weeks	Up to 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Wound Area From Baseline	Wound area measurements will be made via tracing acetate every week for 14 weeks.	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.	Baseline up to 14 weeks

Collaborators and Investigators

• Sponsor: Acera Surgical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Actual): July 15, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: October 1, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot
• Other Study ID Numbers: 17-RES-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes