At a glance
ClinicalIndex Comparison RecordN/ACompleted· 150 enrolled
Drug / intervention
Cardinal Pro +Simultaneous Irrigation (NPWTi) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Negative Pressure Wound Therapy as a Drug Delivery System
University of Texas Southwestern Medical Center·interventional·Posted Jun 4, 2015·Updated Jul 24, 2023
In Brief
A clinical study evaluating Cardinal Pro +Simultaneous Irrigation (NPWTi) and Cardinal Pro (NPWT) Therapy for Diabetic Foot Ulcers. Completed, enrolled 150 participants across 1 site.
Detailed 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 therapy with continuous irrigation and negative pressure wound therapy without irrigation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcers
CountriesUnited States
CollaboratorsParkland Health and Hospital System
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJun 2015
Primary CompletionDec 2019
Study CompletionAug 2020
TodayJul 2026
First PostedJun 4, 2015
Enrollment StartJun 2, 2015
Primary CompletionDec 28, 2019
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 11.1 years ago
Interventions
Cardinal Pro +Simultaneous Irrigation (NPWTi)device
NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
Cardinal Pro (NPWT) Therapydevice
NPWT 125 mm Hg continuous pressure with foam interface