Does HBOT work in the treatment of ischemic diabetic foot ulcers? The results of the multicenter DAMOCLES study suggest not. However, DAMOCLES might be a double edged sword… for the people that didn’t drop out, there appears to be the suggestion of an amputation benefit and lower mortality. See for yourself.
Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower Extremity Ulcers in Patients With Diabetes: Results of the DAMO2CLES Multicenter Randomized Clinical Trial
OBJECTIVE Conflicting evidence exists on the effects of hyperbaric oxygen therapy (HBOT) in the treatment of chronic ischemic leg ulcers. The aim of this trial was to investigate whether additional HBOT would benefit patients with diabetes and ischemic leg ulcers.
RESEARCH DESIGN AND METHODS Patients with diabetes with an ischemic wound (n = 120) were randomized to standard care (SC) without or with HBOT (SC+HBOT). Primary outcomes were limb salvage and wound healing after 12 months, as well as time to wound healing. Other end points were amputation-free survival (AFS) and mortality.
RESULTS Both groups contained 60 patients. Limb salvage was achieved in 47 patients in the SC group vs. 53 patients in the SC+HBOT group (risk difference [RD] 10% [95% CI −4 to 23]). After 12 months, 28 index wounds were healed in the SC group vs. 30 in the SC+HBOT group (RD 3% [95% CI −14 to 21]). AFS was achieved in 41 patients in the SC group and 49 patients in the SC+HBOT group (RD 13% [95% CI −2 to 28]). In the SC+HBOT group, 21 patients (35%) were unable to complete the HBOT protocol as planned. Those who did had significantly less major amputations and higher AFS (RD for AFS 26% [95% CI 10–38]).
CONCLUSIONS Additional HBOT did not significantly improve complete wound healing and limb salvage in patients with diabetes and lower limb ischemia.