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Negative Pressure Wound Therapy as a Drug Delivery System

NCT02463487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-07-24

Study results available
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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.

Conditions

  • Diabetic Foot Ulcers

Interventions

DEVICE

Cardinal Pro +Simultaneous Irrigation (NPWTi)

NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®

DEVICE

Cardinal Pro (NPWT) Therapy

NPWT 125 mm Hg continuous pressure with foam interface

Sponsors & Collaborators

  • Parkland Health and Hospital System

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Lawrence A Lavery, DPM · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-02
Primary Completion
2019-12-28
Completion
2020-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02463487 on ClinicalTrials.gov