CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Restrata® +1 moredevice
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/NCT04918784
NCT04918784N/ACompleted
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Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcer

Acera Surgical, Inc.·interventional·Posted Jun 9, 2021·Updated Sep 28, 2023

In Brief

A clinical study evaluating Restrata® and Wound Dressing for Diabetic Foot Ulcer. Completed, enrolled 46 participants across 1 site.

Detailed Summary

The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects.

Study Details

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

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 9, 2021
Enrollment StartMay 5, 2021
Primary CompletionJul 31, 2022
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.1 years ago

Interventions

Restrata®device

Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.

Wound Dressingdevice

Alginate or Foam wound dressing is intended to manage wounds.