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Hyperbaric oxygen therapy in the treatment of ischemic lower extremity ulcers in patients with diabetes: Results of the DAMO2CLES multicenter randomized clinical trial

Diabetes Care Nov 05, 2017

Santema KTB, et al. - In this present study, the clinicians examined whether additional hyperbaric oxygen therapy (HBOT) would benefit patients with diabetes and ischemic leg ulcers. Among patients with diabetes and lower limb ischemia, additional HBOT did not significantly improve complete wound healing and limb salvage.

Methods
  • The clinicians randomized diabetic patients with an ischemic wound (n = 120) to standard care (SC) without or with HBOT (SC+HBOT).
  • For this study, primary outcomes were limb salvage and wound healing after 12 months, as well as time to wound healing.
  • Amputation-free survival (AFS) and mortality were other end points.

Results
  • In this study, both groups contained 60 patients.
  • In the SC group, limb salvage was achieved in 47 patients vs. 53 patients in the SC+HBOT group (risk difference [RD] 10% [95% CI -4 to 23]).
  • Twenty-eight index wounds were healed in the SC group vs. 30 in the SC+HBOT group (RD 3% [95% CI -14 to 21]) after 12 months.
  • In the SC group, AFS was achieved in 41 patients and 49 patients in the SC+HBOT group (RD 13% [95% CI -2 to 28]).
  • Twenty-one patients (35%) were unable to complete the HBOT protocol as planned in the SC+HBOT group.
  • Those who completed the HBOT protocol as planned had significantly less major amputations and higher AFS (RD for AFS 26% [95% CI 10-38]).
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