Topical Controlled Warm Oxygen Therapy Delivered Through a Novel Device (KADAM™) to Treat Diabetic Foot Ulcers: A Randomized Controlled, Open, Pilot Trial.

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. [ABSTRACT FROM AUTHOR]

Copyright of Indian Journal of Surgery is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)