A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

NCT ID: NCT00605189

Last Updated: 2024-10-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-11-30

Brief Summary

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A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.

Detailed Description

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Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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VAC NPWT

Group Type ACTIVE_COMPARATOR

Powered Suction Pump (VAC Freedom)

Intervention Type DEVICE

continuous foam based negative pressure wound therapy

Gauze-Based NPWT

Group Type ACTIVE_COMPARATOR

Powered Suction Pump

Intervention Type DEVICE

continuous gauze based negative pressure wound therapy

Moist Wound Therapy

Group Type ACTIVE_COMPARATOR

MWT

Intervention Type DEVICE

moist wound therapy

Interventions

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Powered Suction Pump (VAC Freedom)

continuous foam based negative pressure wound therapy

Intervention Type DEVICE

Powered Suction Pump

continuous gauze based negative pressure wound therapy

Intervention Type DEVICE

MWT

moist wound therapy

Intervention Type DEVICE

Other Intervention Names

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VAC Freedom Gauze-Based Negative Pressure Wound Therapy Device

Eligibility Criteria

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Inclusion Criteria

* Type II diabetes
* Subject has a diabetic foot ulcer 5cm squared or greater
* Subject's diabetic foot ulcer is chronic

Exclusion Criteria

* HgbA1c of 12% or greater
* Presence of cellulitis
* Presence of osteomyelitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KCI USA, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gayle M Gordillo, MD

Role: STUDY_DIRECTOR

Ohio State University

Locations

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The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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VACP2005-009

Identifier Type: -

Identifier Source: org_study_id

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