Negative Pressure Wound Therapy as a Drug Delivery System (ADANPWT)
Withdrawn before enrolling · Not applicable
Conditions studied: Foot Ulcer, Diabetic
In brief
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 therapy with continuous irrigation and negative pressure wound therapy without irrigation. The investigators will enroll 150 patients from two centers: The University of Texas Southwestern University Hospital and Parkland Hospital. The investigators will screen and enroll patients with wounds in the inpatient setting. Patients will randomized to receive traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their wound surgically closed during hospitalization will be discharged with negative pressure wound therapy without irrigation for up to a total of four weeks of therapy. After discharge from the hospital, subjects will be seen twice weekly by home health, and the investigators will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or until the wound heals.
Key facts
- Study ID
- NCT02308800
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 0
- Starts
- 2015-01-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2019-01-22
Who can join
Age: 21 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- UT Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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