Status:
WITHDRAWN
Negative Pressure Wound Therapy as a Drug Delivery System (ADANPWT)
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Foot Ulcer, Diabetic
Eligibility:
All Genders
21-89 years
Phase:
NA
Brief Summary
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound t...
Detailed Description
Screening Procedures * Review and sign the Informed Consent and HIPAA Authorization * The study doctor will review the inclusion and exclusion criteria * Demographics (such as age, gender, race or et...
Eligibility Criteria
Inclusion
- Diagnosis of diabetes mellitus
- Men/women ≥21 years old
- Foot or ankle wounds sized 5 cm2 -100 cm2
- ABI≥0.5 or toe pressures \>30 mmHg
Exclusion
- Active Charcot arthropathy
- Unable to use NPWT at home
- Untreated bone or soft tissue infection
- Unable to keep research appointments
- Active alcohol or substance abuse (\> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroine or methamphetamine 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 :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02308800
Start Date
January 1 2015
End Date
December 1 2017
Last Update
January 22 2019
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9132