Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower- Extremity Ulcers in Patients With Diabetes: Results of the DAMO2CLES Multicenter Randomized Clinical Trial

Abstract

Additional HBOT did not significantly improve complete wound healing or limb salvage in patients with diabetes and lower-limb ischemia.

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

“…Taken together, the study by Santema et al (1) showed that a more realistic treatment effect with a larger sample size, along with better matched groups, could have led to significant results in favor of HBOT.…”

“…On closer look at the data in Table 2 in Santema et al (1), readers will notice that the lower bound of the 95% CI in the risk difference column (particularly for limb salvage, amputation-free survival, freedom from amputations index limb, and overall mortality) is very close to 0, meaning that should the study be completed with the initially calculated sample size (n 5 226), the lower bound would probably be above the threshold of statistical significance, i.e., 0.…”

“…A closer look at Table 1 in Santema et al (1) shows that patients in the standard care arm had significantly lower grade wounds (in total, 42% patients had Wagner grade III and IV wounds in the standard care arm vs. 55% in the HBOT arm). The fact that wounds with Wagner grade III and IV have a very high likelihood of osteomyelitis and that patients with osteomyelitis almost always suffer amputation (3) causes a bias toward worse outcomes in the HBOT arm.…”

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

“…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?] trial that hyperbaric oxygen therapy (HBOT) does not confer benefit in the treatment of patients with ischemic foot ulcers and diabetes (3).…”

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

“…study (1) is the only prospective multicenter trial evaluating the effectiveness of hyperbaric oxygen therapy (HBOT) in the treatment of ischemic diabetic foot ulcers (DFUs). By involving 10 hyperbaric facilities across the Netherlands and Belgium, this protocol captures a cross-section of the standard care (SC) in the region with regard to ischemic DFUs but falls victim to variable clinical practice patterns.…”