Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

Abstract

OBJECTIVEHyperbaric oxygen therapy (HBOT) is used for the treatment of chronic diabetic foot ulcers (DFUs). The controlled evidence for the efficacy of this treatment is limited. The goal of this study was to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with diabetes and chronic DFUs. RESEARCH DESIGN AND METHODSPatients with diabetes and foot lesions (Wagner grade 2-4) of at least 4 weeks' duration participated in this study. In addition to comprehensive wound care, participants were randomly assigned to receive 30 daily sessions of 90 min of HBOT (breathing oxygen at 244 kPa) or sham (breathing air at 125 kPa). Patients, physicians, and researchers were blinded to group assignment. At 12 weeks postrandomization, the primary outcome was freedom from meeting the criteria for amputation as assessed by a vascular surgeon. Secondary outcomes were measures of wound healing. RESULTSOne hundred fifty-seven patients were assessed for eligibility, with 107 randomly assigned and 103 available for end point adjudication. Criteria for major amputation were met in 13 of 54 patients in the sham group and 11 of 49 in the HBOT group (odds ratio 0.91 [95% CI 0.37, 2.28], P = 0.846). Twelve (22%) patients in the sham group and 10 (20%) in the HBOT group were healed (0.90 [0.35, 2.31], P = 0.823). All other indices of wound healing were also not statistically significantly different between groups. CONCLUSIONSHBOT does not offer an additional advantage to comprehensive wound care in reducing the indication for amputation or facilitating wound healing in patients with chronic DFUs.

Update on management of diabetic foot ulcers

“…In 2016, Fedorko et al published a double-blinded RCT concluding that HBOT therapy does not reduce indication for amputations in patients with Wagner grade 2-4 DFUs as assessed by a vascular surgeon after 12 weeks of HBOT. 52 This study has been criticized because the end points were not amputation events. [53][54][55] Rather, the primary outcome was whether the patient met criteria for amputation, which was a decision made by a vascular surgeon based on a photograph of the wound.…”

Comment on Fedorko et al. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care 2016;39:392–399

“…Fedorko et al (1) claim that their study population is similar to that of Löndahl et al (4). This is not correct, as that study population was older; had a longer diabetes duration, a minimum ulcer duration of 3 months, a longer prespecified minimum prestudy period in a diabetic foot ulcer clinic; and had more comorbidities and higher rates of previous amputation (almost 50 vs. 6%) and previous vascular surgical intervention (55 vs. 12%) at baseline.…”

10. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes—2018

“…However, multiple subsequently published studies have either failed to demonstrate a benefit of HBOT or have been relatively small with potential flaws in study design (135). A well-conducted randomized controlled study performed in 103 patients found that HBOT did not reduce the indication for amputation or facilitate wound healing compared to comprehensive wound care in patients with chronic diabetic foot ulcers (138). A systematic review by the International Working Group on the Diabetic Foot of interventions to improve the healing of chronic diabetic foot ulcers concluded that analysis of the evidence continues to present methodological challenges as randomized controlled studies remain few with a majority being of poor quality (135).…”