RCT to Compare Restrata and NPWT to Heal Complex DFUs

Withdrawn before enrolling · Phase 4

Conditions studied: Diabetic Wound

In brief

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.

Key facts

Study ID: NCT04405050
Run by: University of Texas Southwestern Medical Center
People needed: 0
Starts: 2021-06-01
Expected to finish: 2023-07-01
Last updated by the study team: 2023-07-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

UT Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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