A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs

NACompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions
Diabetic Foot Ulcer
Interventions
DEVICE

CDO electrochemical tissue oxygenation system

The TransCu O2® device is a non-invasive, electrochemical tissue oxygenation system intended for use with lower-cost wound dressings for the treatment of chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers and other skin wounds through the continuous diffusion of oxygen (CDO). The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing

DEVICE

Moist Wound Therapy

Moist Wound Therapy in combination with sham or deactivated device

Trial Locations (33)

16602

Clinical Research Associates of Central PA, Altoona

19041

Foot and Ankle Center, Haverford

20895

Foot and Ankle Specialists of the Mid-Atlantic, Kensington

21122

Foot and Ankle Specialists of the Mid-Atlantic, Pasadena

21401

Foot and Ankle Specialists of the Mid-Atlantic, Annapolis

28144

PMG Research of Salisbury, Salisbury

28401

PMG Research of Wilmington, LLC, Wilmington

30907

Aiyan Diabetes Center, Martinez

33013

The Research Center, Hialeah

33143

Doctors Research Network, South Miami

33165

Phoenix Medical Research, Miami

33406

Orthopedic Research Institute, West Palm Beach

60016

Weil Foot & Ankle Institute, Des Plaines

60616

Weil Foot & Ankle Institute, Chicago

75224

Richard C. Galperin, DPM, PA, Dallas

76051

William Blake Partners, LLC, Grapevine

77074

Houston Foot & Ankle, Houston

78212

Alamo Clinical Research, San Antonio

78229

Clinical Trials of Texas, San Antonio

The University of Texas Health Science Center at San Antonio, San Antonio

78501

Complete Family Foot Care, McAllen

79606

Integrated Clinical Research, Abilene

84107

Clinical Research Medical Center, Salt Lake City

85015

Associated Foot and Ankle Specialists, Phoenix

85306

Clinical Trials of Texas, Inc., dba Clinical Trials of Arizona, Inc., Glendale

85712

Premier Foot & Ankle Surgeons, Tucson

85723

Southern Arizona VA Health Care System, Tucson

89106

Clinical Research Medical Center, Las Vegas

Impact Clinical Trials, Las Vegas

93710

Roy O. Kroeker, DPM , Inc., Fresno

93721

Limb Preservation Platform, Fresno

94115

Center for Clinical Research, Inc, San Francisco

95628

Sacramento Foot & Ankle Center, Fair Oaks

All Listed Sponsors
lead

Electrochemical Oxygen Concepts, Inc.

INDUSTRY

NCT01645891 - A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs | Biotech Hunter | Biotech Hunter