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RCT to Compare Restrata and NPWT to Heal Complex DFUs

NCT04405050 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-07-24

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy of Restrata compared to Negative Pressure Wound Therapy (NPWT) to heal complex diabetic foot wounds.

Conditions

  • Diabetic Wound

Interventions

DEVICE

Restrata

Restrata® is a novel synthetic nanofabricated scaffold (Restrata Wound Matrix (RWM), Acera Surgical, St. Louis, Missouri) has been developed which is a sterile, single-use device intended for use in the local management of wounds. The RWM is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur (Figure 2). The RWM is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native ECM. As a viable wrap for surgical procedures, Restrata conforms to injured tissue, can be sutured, and is arthroscopic and robotic procedure friendly.

DEVICE

Negative Pressure Wound Therapy (NPWT)

Negative Pressure Wound Therapy (NPWT) has dramatically changed the care of complex foot wounds. Compared to standard wound care, patients with diabetic foot wounds that are treated with NPWT are 5.9 times more likely to heal and 4.4 times less likely to require amputation. NPWT involves the delivery of sub-atmospheric pressure through a vacuum pump connected to a specialized dressing to maintain a closed environment. NPWT increases perfusion to the wound, accelerates granulation tissue formation, reduces edema, and reduces bio-burden

Sponsors & Collaborators

  • Acera Surgical, Inc.

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Lawrence Lavery, DPM MPH · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-07-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04405050 on ClinicalTrials.gov