An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (Natrox™) on the Rates of Healing of Chronic DiAbetic Foot Ulcers (OTONAL Trial)

Autor:	J. E. C. Boey, Manfred Mak, Xin Jie Soh, Sze Ling Chan, R. W. L. Lee, Tjun Y. Tang, Charyl Jq Yap, I. A. B. Ishak, Wan Xi Goh, Shereen X. Y. Soon
Rok vydání:	2021
Předmět:	business.industry medicine.medical_treatment Ischemia General Medicine medicine.disease Revascularization Diabetic foot Diabetic foot ulcer Amputation Anesthesia Concomitant Oxygen therapy Ambulatory medicine Surgery business
Zdroj:	The International Journal of Lower Extremity Wounds. :153473462110536
ISSN:	1552-6941 1534-7346
DOI:	10.1177/15347346211053694
Popis:	Natrox™topical oxygen therapy (TOT) ( Inotec AMD Ltd, Cambridgeshire, UK) employs a small battery-powered “oxygen generator” to concentrate atmospheric oxygen and feeds pure, moist, oxygen through a fine, soft tube to a dressing-like “oxygen distribution system”, which is placed over the wound and is held in place by a conventional dressing. The aim was to determine the effectiveness of Natrox™for non-healing diabetic foot ulcers (DFU) over a 3-month period.Longitudinal, single-arm, open prospective registry study using 12 weeks of TOT using a 4 week run-in period. 20 patients recruited to OTONAL had chronic DFU greater than 3 months duration or minor amputation sites with less than 50% healing in 4 weeks.There were 13 (65%) males and the mean age was 65.7 (±11.6) years. The mean glycated haemoglobin (HbA1c) was 6.9 (±1.3) mmol mol−1and mean wound duration before TOT was 114 (±79.1) days. 18/20 (90.0%) patients had concomitant lower limb revascularization angioplasty for chronic limb threatening ischaemia. The mean size of the foot ulcer at baseline was 11.3 ± 14.8 cm2and mean transcutaneous oxygen measurement value was 34.1 (±19.6) mm Hg. Wound closure of >75% was observed in 14/20 (70.0%) patients. There was a 91.3% (±14.9%) wound area reduction by 3 months (P = .001) and mean time for 100% closure was 77.6 ± 32.5 days. Mean pain scores reduced from 2.4 (±1.8) at baseline to .5 (±1.0) at 3 months (P = .008). All patients were very satisfied using the ambulatory device. Use of TOT in chronic diabetic foot wounds stimulates a healing state, underpinning the concept that oxygen plays a central role in wound healing. Our results are more compelling if you consider they started with relatively large-sized DFUs and majority of patients were frail with underlying peripheral artery disease. (NCT03863054)
Databáze:	OpenAIRE
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