a) Background
Diabetic foot ulcer (DFU) is one of the common complications seen in diabetes mellitus. Approximately 15% of diabetic patients develop foot ulcers in their life time and this is known to precede amputation in 85% of the cases . In India, the prevalence of diabetic foot ulcers in the clinic population is 3.6%.
The complications associated with such ulcers can be prevented by multidisciplinary approach in wound management. Apart from the regular measures like blood sugar control, wound debridement, in some cases topical oxygen therapy, hyper baric oxygen therapy, electrical stimulation, bio-engineered skin and growth factors may be used as adjunct therapies to speed up the healing process
Hyperbaric oxygen therapy (HBOT) is one of the approved application used as adjunctive therapy for non-healing wounds such as diabetic and vascular insufficiency ulcers .
b) Objective
To assess the efficacy of topical warm oxygen therapy on top of standard of care compared with standard care alone on the wound healing rate.
c) Methods
This was a parallel group study. We had randomly assigned 20 participants in a 1:1 ratio using SAS-based computer-generated randomization scheme developed by the study data management provider. We used block randomization with random permuted blocks. The investigator would complete a randomization worksheet as detailed in the study manual and fax it to the central project office. The allocation was then be disclosed by telephone to the investigator.
d) Results
- 5 patients in the control group had a worsening of ulcer area as compared to 1 patient in the intervention group at the end of 6 weeks.
- 2 patients in the control group had 3 serious adverse events related to worsening of the ulcer area and suppuration requiring hospitalization. 2 of these hospitalizations resulted in amputation/ invasive intervention procedures. In contrast, no participant in the intervention group needed hospitalization. There were no amputations in the intervention group.
Our study demonstrated a statistically significant difference in ulcer areas between the intervention and control groups at 6 weeks follow-up, with the log (area of ulcer) sq.cm in intervention group being significantly smaller. The intervention group also demonstrated a statistically significant reduction in within the group ulcer area at 6 weeks and 12 weeks respectively. The within group reductions in ulcer area in the control group were statistically not significant. There were no adverse reactions related to the intervention in the intervention group and the warm topical oxygen therapy was generally well tolerated throughout the duration of the intervention
e) Total recruitment & no. of sites
20 subjects were recruited from 1 site in India.
f) Conclusion
The results of the STRIDE pilot study indicate that topical controlled, warm oxygen (at 41 ?C, 1 liter per minute) delivered through the KADAM device was well tolerated by patients with lower limb ulcers (Wagner Meggit II/III) and moderately well controlled type 2 diabetes (HbA1c < 10>
g) Publication status (Name & year):
Indian Journal of Surgery, 2021
h) Publication link
https://link.springer.com/content/pdf/10.1007/s12262-021-03057-w.pdf
Updated as on: 18 Jul 2022