Comment on Santema et al. 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 2018;41:112–119

Response to Comments on Santema et al. 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 2018;41:112–119

“…We disagree that these limitations render our results "highly questionable" (1) or would suggest HBOT is a "viable adjunctive treatment for enhancing amputationfree survival in the ischemic" diabetic foot ulcer (2). Rather, we believe they provide food for thought, as it remains open for discussion whether our conclusions would have been different or even clinically more relevant if we would have been able to include the initially planned number of patients.…”

“…Mutluoglu (1) and Huang (2) for their critical comments. They both express concerns regarding our conclusion based on the results of the DAMO 2 CLES [Does Applying More Oxygen (O 2 ) Cure Lower Extremity Sores?]…”

On the Cutting Edge: Wound Care for the Endovascular Specialist

“…121 Unfortunately, this trial was plagued by poor enrollment and high dropout rates, failing to meet its initial calculated required sample size and with only 65% of the HBOT group completing the protocol. 121,122 This resulted in varying results: when examined from a per protocol intention-to-treat analysis, no significant difference was noted in limb salvage rates between the two groups; however, among patients who actually completed the trial, the patients who received HBOT had statistically significant higher rates of limb salvage (SC group 78% vs. SC þ HBOT group 95%). 121,122 Despite its criticisms, the DAMO2CLES trial does hint that many CLI patients may be unable to complete a rigorous HBOT regimen necessary to provide substantial benefit.…”

“…121,122 This resulted in varying results: when examined from a per protocol intention-to-treat analysis, no significant difference was noted in limb salvage rates between the two groups; however, among patients who actually completed the trial, the patients who received HBOT had statistically significant higher rates of limb salvage (SC group 78% vs. SC þ HBOT group 95%). 121,122 Despite its criticisms, the DAMO2CLES trial does hint that many CLI patients may be unable to complete a rigorous HBOT regimen necessary to provide substantial benefit. 121,122 In summary, there remains a paucity of well-designed studies in this area, precluding the creation of societal recommendations for or against the use of HBOT in these patients.…”

“…121,122 Despite its criticisms, the DAMO2CLES trial does hint that many CLI patients may be unable to complete a rigorous HBOT regimen necessary to provide substantial benefit. 121,122 In summary, there remains a paucity of well-designed studies in this area, precluding the creation of societal recommendations for or against the use of HBOT in these patients.…”