CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Restrata TM Wound Matrixdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03312595
NCT03312595N/ACompleted
CompareCT.gov

Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures

Acera Surgical, Inc.·interventional·Posted Oct 18, 2017·Updated Sep 16, 2025

In Brief

A clinical study evaluating Restrata TM Wound Matrix for Diabetic Foot Ulcer. Completed, enrolled 30 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 18, 2017
Enrollment StartSep 14, 2017
Primary CompletionJul 15, 2018
Study CompletionJul 30, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.7 years ago

Interventions

Restrata TM Wound Matrixdevice

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