Topical Wound Oxygen Therapy for Treatment of Diabetic Foot Ulcers
Research type
Research Study
Full title
A Multi-national, Multi-center, Prospective, Randomized, Double Blinded, Placebo-controlled Trial to Evaluate the Efficacy of HyperBox Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers
IRAS ID
177936
Contact name
Mike Griffiths
Contact email
Sponsor organisation
AOTI Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 4 days
Research summary
This study is being conducted in people with diabetic foot ulcers (DFU). About 66,000 nontraumatic lower- limb amputations performed in diabetics annually (180/day) and one every 30 seconds worldwide. Amputation costs are high and the chance of dying by five years is over 50%. This study will assess how well Topical Wound Oxygen Therapy (TWO2) works when applied directly to DFUs. The study will also be looking at how safe the treatment is, if it is cost effective and if it improves the quality of life for people with DFUs. The TWO2 device has been in use for many years but the treatment is not widely available as the best form of investigation called a double blind, randomized controlled study has never been conducted. This means the TWO2 should be compared to a dummy treatment, but the doctor and patient will not know which treatment is which.
Subjects on this study have a 50 percent chance of being assigned to either TWO2 or a dummy device plus standard of care treatment (dressings and off-loading boot). The TWO2/Dummy therapy will be conducted at home or equivalent, not in the clinic. The treatment period with TWO2/Dummy is up to 12 weekly treatment visits with a startup phase of 2 weeks and a follow up phase of 12 and 38 weeks. For the DFUs that do not heal by 12 weeks, the doctor will choose another approved form of treatment.
The study is being conducted in Europe and North America. Up to 220 people will participate, but the study is designed to stop early if it is found to be very effective early on and will be reviewed after one third and then two thirds of patients are recruited. The study may take up to 3 years to complete.REC name
South East Scotland REC 02
REC reference
15/SS/0171
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion