Authors' objectives: HTW originally aimed to identify and summarise evidence that addresses the following question: What is the clinical and cost effectiveness of continuous topical oxygen therapy (TOT) in addition to standard of care for the treatment of chronic non-healing and complex wounds in comparison to standard of care alone? The majority of the evidence, and the evidence of highest certainty, we identified was for diabetic foot ulcers, and we have therefore focused on this wound type (evidence on other wound types is reported in an appendix of the report).

Authors' results and conclusions: We identified one meta-analysis, one systematic review, three additional randomised controlled trials and one study reporting longer-term follow up from one of the included randomised controlled trials. Continuous TOT plus standard of care significantly increased complete diabetic foot ulcer healing compared to standard of care alone, after up to 12 weeks of follow-up. Continuous TOT, in combination with standard of care, also reduced the time to diabetic foot ulcer closure and reduced the wound size compared to standard of care alone. The risk of amputation at one-year was significantly lower in those diabetic foot ulcers treated with a combination of continuous TOT, moist wound therapy and standard of care, compared to continuous TOT plus standard of care or moist wound therapy plus standard of care. The evidence suggests that one-year wound recurrence rates are lower in people treated with continuous TOT plus standard of care, compared with standard of care alone. The evidence reports that continuous TOT devices are well-tolerated by people with diabetic foot ulcers. The evidence showed no significant reduction in pain, the number of infections/incidents of cellulitis, 12-week wound recurrence rates or 12-week amputation rates following continuous TOT and standard of care, versus standard of care alone. Additionally, there were no significant differences between the treatment groups in the number of adverse events or serious adverse events. A de-novo cost-utility analysis was conducted to evaluate the cost effectiveness of treating patients with diabetic foot ulcers with continuous TOT in addition to standard of care, compared with standard of care alone, from the perspective of treatment in NHS Wales. Due to a higher wound healing rate with continuous TOT in addition to standard of care, as well as a reduction in amputation events and infection, there was greater benefit to patients at a lower cost compared to standard care alone. Treatment with continuous TOT in addition to standard of care is therefore dominant, when compared to standard of care alone.

Authors' recommendations: The evidence supports the routine adoption of continuous TOT to treat patients with chronic non-healing and complex diabetic foot ulcers. The use of continuous TOT, in addition to standard of care, increases the number of wounds with complete wound healing and reduces the wound area and time to healing, as compared with standard of care alone. Economic analysis indicates that the use of continuous TOT results in a greater benefit to patients at lower cost compared with standard of care. Cost savings of £211 per patient are estimated. When considering the projected prevalence of chronic non-healing and complex diabetic foot ulcers over the next 5 years in Wales, this could translate to total cost-savings of £8,637.

Authors' methods: The Evidence Appraisal Report is based on a literature search (strategy available on request) for published clinical and economic evidence on the health technology of interest. It is not a full systematic review but aims to identify the best available evidence on the health technology of interest. Researchers critically evaluate and synthesise this evidence. We include the following clinical evidence in order of priority: systematic reviews; randomised trials; non-randomised trials. We only include evidence for “lower priority” evidence where outcomes are not reported by a “higher priority” source. We also search for economic evaluations or original research that can form the basis of an assessment of costs/cost comparison. We carry out various levels of economic evaluation, according to the evidence that is available to inform this.

Authors' identified further research: The Appraisal Panel would welcome further research into the comparative effectiveness of continuous TOT and other advanced therapies for the treatment of diabetic foot ulcers. Furthermore, research to determine the effectiveness of continuous TOT on wound healing in diabetic foot ulcers of different grades is also recommended.

Project Status: Completed

Year Published: 2022

URL for published report: https://healthtechnology.wales/reports-guidance/topical-oxygen-therapy-natrox/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Wales, United Kingdom

Organisation Name: Health Technology Wales

Contact Address: c/o Digital Health Care Wales, 21 Cowbridge Road East Cardiff CF11 9AD

Contact Name: Susan Myles, PhD

Contact Email: healthtechnology@wales.nhs.uk

Copyright: Health Technology Wales