Effect of gas plasma (charged gas) on infected diabetic foot ulcers
Research type
Research Study
Full title
A randomised controlled trial to evaluate the efficacy of non-thermal gas plasma (NTGP) on sub-clinical wound infection (biofilm) in patients with diabetic foot ulcers compared to those treated with standard of care dressings.
IRAS ID
198288
Contact name
Steven Jeffery
Contact email
Sponsor organisation
Adtec Europe Ltd
ISRCTN Number
ISRCTN17491903
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study seeks to investigate if gas plasma (charged gas) is effective in managing infection in diabetic foot ulcers. It is proposed to recruit 60 participants with diabetes, who have foot ulcers where healing is stalled for at least 4 weeks. 30 participants will receive gas plasma and standard care dressings (SCD) and 30 will receive sham gas plasma and SCD. Participants will be treated twice weekly. Each gas plasma or sham treatment will last 5 minutes. Treatment will be administered in a hospital podiatry clinic and the study will last for 4 weeks Foot ulcers are the most common, disabling and costly complication of diabetes. Infection in the diabetic foot is a major cause of morbidity (amputation), death and infection is a primary impediment to ulcer healing. Infection can demonstrate resistance to antibiotic treatment. Gas plasma is a known effective/safe treatment for chronic infected wounds and does not cause antibiotic resistance. Participants will undergo wound photography, wound surface swabs, removal of any dead tissue from the wound surface, and the taking of wound tissue samples (biopsy). The biopsies will be taken 4 weeks apart and examined for any changes. The study is important to investigate the effectiveness of gas plasma treatment for diabetic foot ulcers and the potential to thereby reduce amputations. Effectiveness of treatment will be evaluated through reduction in wound volume as measured by a validated digital imaging system.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0476
Date of REC Opinion
20 Jan 2017
REC opinion
Further Information Favourable Opinion