Continuous topical oxygen therapy
Topic Status Complete
Continuous topical oxygen therapy to treat people with chronic non-healing and complex diabetic foot ulcers
Outcome of the appraisal
The evidence supports the routine adoption of continuous topical oxygen therapy to treat patients with chronic non-healing and complex diabetic foot ulcers. The use of continuous topical oxygen therapy, 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 topical oxygen therapy 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
Why was this topic appraised?
Diabetic foot ulcers are the largest single reason for hospital admission in people with diabetes. They can lead to significant morbidity and mortality and can have a large detrimental impact on quality of life. In people with diabetes, the circulation to the legs is often impaired due to the development of occlusive disease in the large and small blood vessels that supply blood and oxygen to the lower limbs.
Continuous topical oxygen therapy has therefore been proposed as a means of improving wound healing through continuously supplying an external flow of pure oxygen through small tubes directly into the wounds themselves. This topic was submitted by Inotec AMD Limited, manufacturers of a continuous topical oxygen therapy device called NATROX.
Lay summary
Diabetic foot ulcers (DFUs) may occur in approximately 10% of people with type 1 and 2 diabetes. A DFU is an open wound or sore on the skin that’s slow to heal. When blood sugar levels are high or fluctuate regularly, skin that would normally heal may not properly repair itself because of nerve damage. This can make them more complicated to manage than other chronic wounds. If left untreated, the affected foot may need amputation.
Oxygen is an important part of wound healing, as it promotes the production of new, healthy skin. A lack of oxygen (hypoxia) can delay healing and increase the risk of complications. People with diabetes are more likely to have hypoxia, making their wounds harder to heal.
Topical oxygen therapy (TOT) is a way of delivering 100% oxygen directly to the wound area. There are many ways of delivering TOT. Continuous TOT devices work by generating a continuous application of pure oxygen to the wound dressing through tubes. They are small, portable and battery-powered, so they can be used across healthcare settings and can be taken home for use by the patient or carer.
Health Technology Wales looked for evidence on the clinical and cost effectiveness of continuous topical oxygen therapy to treat people with chronic non-healing and complex diabetic foot ulcers. The evidence supports the routine adoption of continuous topical oxygen therapy to treat patients with chronic non-healing and complex diabetic foot ulcers. The use of continuous topical oxygen therapy, 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.
Topic Exploration Report
TER329 02.2022
Evidence Appraisal Review
EAR043 09.2022
Guidance
GUI043 09.2022
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