Status:
WITHDRAWN
RCT to Compare Restrata and NPWT to Heal Complex DFUs
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Acera Surgical, Inc.
Conditions:
Diabetic Wound
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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.
Detailed Description
Screening 1. Explain purpose and nature of the study and obtain signature on the informed consent document. 2. Screen the subject against protocol inclusion and exclusion criteria, including all pert...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04405050
Start Date
June 1 2021
End Date
July 1 2023
Last Update
July 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390