RCT to Compare Restrata and NPWT to Heal Complex DFUs

NCT04405050 | Withdrawn Phase 4 FDA Device

• 1 other identifier: 2020-0268
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  The primary objective of this trial is to evaluate the incidence of wound closure. Closure is defined as complete epithelialization with no drainage.

  12 weeks

Secondary Outcomes (2)

• Time to wound healing

  12 weeks

• Differences in wound healing trajectories

  12 weeks

Study Arms (2)

Restrata

ACTIVE COMPARATOR

Treated with Restrata

Device: Restrata

NPWT

ACTIVE COMPARATOR

Treated with NPWT (Negative Pressure Wound Therapy)

Device: Negative Pressure Wound Therapy (NPWT)

Interventions

Restrata DEVICE

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.

Restrata

Negative Pressure Wound Therapy (NPWT) DEVICE

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

NPWT

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a diabetes mellitus
• Men/women ≥21 years old
• Post-operative foot or ankle wounds sized \< 15cm
• ABI ≥0.5 or toe pressures \>30 mmHg
• Wounds indicated for treatment with NPWT

You may not qualify if:

• Active Charcot arthropathy
• Unable to use NPWT at home
• Untreated bone or soft tissue infection
• Is pregnant or plans to become pregnant
• Is nursing or actively lactating
• Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
• Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials. Active alcohol (\> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroin, or methamphetamines or if drug or alcohol use will interfere with follow-up visits in foot clinic in the opinion of the investigator

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Acera Surgical, Inc.: collaborator

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Lawrence Lavery, DPM MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Research

Model Details: This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare Restrata and NPWT in patients with complex diabetic foot ulcers.

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: June 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)