Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
Completed · Not applicable · Has a placebo group
Conditions studied: Diabetic Foot Ulcer
In brief
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.
Key facts
- Study ID
- NCT02326337
- Run by
- AOTI Ltd.
- People needed
- 73
- Starts
- 2014-10-01
- Expected to finish
- 2018-10-25
- Last updated by the study team
- 2025-10-27
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject has a documented diagnosis of Diabetes mellitus Type 1 or 2
- Foot ulcer at or below ankle with duration of more than 4 weeks but no longer than 1 year
- If the index ulcer is a post amputation wound date of surgery must be > 30 days
- 2 week run in period with less than 30% wound size reduction
- University of Texas Grade 1A, 1B, 1C, 1D, 2A, 2B, 2C, or 2D (Appendix I)
- Ulcer is ≥ 1cm2 and ≤ 20cm2 after debridement at start of run-in period
- If more than one ulcer is present on the foot, only the largest is considered in the study (Index ulcer)
- Index ulcer must be ≥ 1cm away from any other ulcers present on the foot
- Adequate perfusion with ABI > 0.7 And TcpO2 > 30mmHg OR skin perfusion > 30mmHG OR Toe pressure > 30mmHg OR Duplex with biphasic waveforms below the knee
- No planned revascularization procedure or vascular surgery within the last/next 30 days
- Subject and/or caregiver are willing and able to comply with all specified care and visit requirements
- Subject has a reasonable expectation of completing the study; according to the Investigator's clinical judgment
You may not qualify if…
- Evidence of gangrene on any part of affected limb
- Documented evidence of osteomyelitis on any part of affected limb
- Index ulcer has exposed bone
- Index ulcer exhibits signs of severe clinical infection that requires hospitalization or immediate surgical intervention
- Active Charcot foot on the study limb
- Subject participated in another investigational device, drug or biological trial within last 30 days
- Uncontrolled diabetes: HbA1c > 12 %
- Renal dialysis or creatinine > 2.5
- Known immune insufficiency
- Chronic steroid use or immunosuppressive agents within the last three (3) months or is anticipated to require them during the course of the study
- Active treatment for malignancy (not specific to study limb)
- Patient has a Deep Vein Thrombosis within the last 30 days
- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within the screening period
- Subject may not be pregnant at the time of treatment
Where it is running
- Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States
- NorthBay Center for Wounds — Vacaville, California, United States
- Washington DC VA Medical Center — Washington D.C., District of Columbia, United States
- The Research Center Inc. — Hialeah, Florida, United States
- Advanced Research Institute of Miami — Miami, Florida, United States
- Advanced Research Institute of Miami — Miami, Florida, United States
- Edward Hines, Jr. VA Hospital — Chicago, Illinois, United States
- Advanced Foot & Ankle Center — Las Vegas, Nevada, United States
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
- Salem VA Medical Center — Salem, Virginia, United States
- Avicenne Hospital — Bobigny, France
- Hospital Simone Veil — Eaubonne, France
- Montpellier University Hospital — Montpellier, France
- Städtisches Klinikum Dessau — Dessau, Germany
- Kirchberg Hospital — Luxembourg, Luxembourg
- Northwick Park Hospital — Harrow, United Kingdom
- King's College Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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