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.