Abstract
Adjunctive topical oxygen therapy offers promise in accelerating diabetic foot ulcer healing. We hypothesize that topical warm oxygen delivered at a controlled temperature (42 °C) through a proprietary device (KADAM™) will improve ulcer healing and be well-tolerated among patients with type 2 diabetes mellitus and with foot ulcers of Wagner-Meggitt grades 2 and 3. This trial employed a randomized controlled, open label design, with the outcome assessor blinded to allocation. We randomized 20 patients in a 1:1 allocation ratio, to intervention and control (standard of care) arms. The intervention arm received in-hospital topical warm oxygen at 42 °C for 90 min/session. This was repeated on alternate days for 6 weeks (18 sessions). Patients in the control group got standard care, and all received standard wound care. The primary outcome was a change in the ulcer area from baseline visit to follow-up at 6 weeks, day 5. There was a significant reduction in the area of the ulcer in the intervention group between baseline and week 6, day 5 [log area intervention group baseline vs week 6 day 5, 2.72 (0.57) vs 1.54 (0.95), change = − 1.18 (− 0.58, − 1.78), p = 0.019]. Between-group ulcer area at week 6, day 5, was also significantly different [intervention vs control (log area), 1.54 (0.95) vs 2.94 (1.05), p = 0.005], with the difference favoring the intervention group. There were no adverse reactions in the intervention arm. Adjunctive topical warm oxygen delivered at 42 °C and normal pressure can potentially improve diabetic foot ulcer healing and is well-tolerated.
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The data are currently in the possession of the investigators of the study. We can consider making the de-identified data available upon request. Please contact the corresponding author for requests pertaining to data access.
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Dr. Anirudh V, Dr. Deepak Kamath (Kamath DY), Dr. Bhuvana KB, and Dr. Denis Xavier (Xavier D) were contracted by Yostra Labs Pvt Ltd, Bengaluru India, to develop the protocol and conduct the trial. They have not availed of any personal fees for this purpose, with the funds being utilized solely for study conduct and coordination. Dr. Maruthy K and Dr. Sanjay Sharma (Sharma S) are co-founders of Yostra Labs Pvt Ltd and are the principal grant recipients from DBT-BIRAC. Dr. Maruthy K has been involved with protocol development and have advised on matters related to the intervention. Yostra Labs Pvt Ltd does not own the data and has not been involved in the analysis, but Dr Maruthy K and Dr Sanjay Sharma have reviewed the manuscript. Dr. Prem Pais (Pais P) has no relevant conflicts of interest to declare.
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Anirudh, V., Kamath, D.Y., Ghosh, S. et al. Topical Controlled Warm Oxygen Therapy Delivered Through a Novel Device (KADAM™) to Treat Diabetic Foot Ulcers: A Randomized Controlled, Open, Pilot Trial. Indian J Surg 83 (Suppl 4), 907–914 (2021). https://doi.org/10.1007/s12262-021-03057-w
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DOI: https://doi.org/10.1007/s12262-021-03057-w