Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers

NACompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

February 5, 2018

Study Completion Date

October 25, 2018

Conditions
Diabetic Foot Ulcer
Interventions
DEVICE

TWO2 Device

Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.

DEVICE

Placebo Device

Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.

Trial Locations (17)

20422

Washington DC VA Medical Center, Washington D.C.

23249

Hunter Holmes McGuire VA Medical Center, Richmond

24153

Salem VA Medical Center, Salem

33012

Advanced Research Institute of Miami, Miami

33013

The Research Center Inc., Hialeah

33134

Advanced Research Institute of Miami, Miami

34000

Montpellier University Hospital, Montpellier

60141

Edward Hines, Jr. VA Hospital, Chicago

85012

Carl T. Hayden VA Medical Center, Phoenix

89119

Advanced Foot & Ankle Center, Las Vegas

93000

Avicenne Hospital, Bobigny

95600

Hospital Simone Veil, Eaubonne

95687

NorthBay Center for Wounds, Vacaville

06847

Städtisches Klinikum Dessau, Dessau

L-2540

Kirchberg Hospital, Luxembourg

HA1 3UJ

Northwick Park Hospital, Harrow

SE5 9RS

King's College Hospital, London

All Listed Sponsors
lead

AOTI Ltd.

INDUSTRY

NCT02326337 - Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter