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A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

NCT01013792 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-02

Study results available
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Summary

The primary objective is to:

* Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.

Secondary objectives are to:

* Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology.
* Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology.
* Assess and compare the impact that these dressings have on patients' quality of life.
* Assess the wound's biological response and pH to the study dressings.

Conditions

  • Foot Ulcer, Diabetic

Interventions

DEVICE

Wound Dressing

Acetate mesh carrier with ointment (water, PEGs)

DEVICE

Wound Dressing

Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • Solventum US LLC

    lead INDUSTRY

Principal Investigators

  • Joseph V Boykin, MD · HCA Retreat Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-07-31
Completion
2012-07-31

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 NCT01013792 on ClinicalTrials.gov