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

April 6, 2021 updated by: Acera Surgical, Inc.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Restrata TM Wound Matrix
Prospective, single armed, non-randomized study with direct assignment
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
Time Frame: Up to 14 weeks
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
Time Frame: Baseline and weekly for up to 14 weeks
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
Time Frame: Baseline up to 14 weeks
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (ACTUAL)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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