May 2013

How Effective Is HBOT For Diabetic Foot Ulcers?

By Brian McCurdy, Senior Editor

Although a recent study concludes that hyperbaric oxygen therapy (HBOT) is not effective for healing diabetic wounds, several physicians note that HBOT does have a benefit as an adjunctive treatment for non-healing diabetic foot ulcers.

   The longitudinal observational cohort study, published in Diabetes Care, focused on 6,259 patients with diabetes, adequate lower limb arterial perfusion and foot ulcers extending through the dermis. In their propensity score–adjusted models, researchers note that those receiving HBOT were less likely to heal their foot ulcer and more likely to have an amputation than those using conventional therapies. The study authors concluded that HBOT would not improve the likelihood that a wound might heal or decrease the likelihood of amputation. They add that the “usefulness of HBO in the treatment of diabetic foot ulcers needs to be reevaluated.”

   Phi-Nga Jeannie Le, MD, notes that the Diabetes Care study only “appears to contradict” previous studies that established the efficacy of HBOT for healing diabetic foot ulcers. Dr. Le notes the study is an effectiveness study rather than an efficacy study.

   “The two are not equatable,” says Dr. Le, who is affiliated with the Undersea and Hyperbaric Medical Society. “They signify two different objectives. One tries to determine if something actually works (efficacy) and the other tries to discern if that something has been beneficially employed (effectiveness).”

   As Dr. Le says, this study does not deny that HBOT is efficacious as adjunctive treatment for healing diabetic wounds and preventing major amputation, but it does conclude that HBOT has not displayed the same beneficial outcomes in an existing clinical practice as it has in several clinical trials. For situations when amputation is necessary, she says HBOT can obviate a major amputation by exchanging it for a minor amputation, an exchange generally agreed to increase quality of life. Dr. Le adds that the Diabetes Care study classifies any amputation as a negative outcome so one could not identify the beneficial effects of minor amputations in the study.

   Lee Brill, DPM, CWS, the President of the BrillStone Corporation in Dallas, says his center has had good results with HBOT. However, he notes that HBOT does not replace good wound care and debridement as well as establishing adequate perfusion and control of infection before and during HBOT.

   “Rather than showing the lack of effectiveness of HBOT,” the study raises questions for Dr. Brill. Among those questions, he asks how many patients in the study had subsequent osteomyelitis after a series of HBOT treatments due to inadequate workup prior to treatment? Dr. Brill also questions how many patients had inadequate debridement during HBOT treatment and whether offloading was standard throughout the patient population.

   “I agree that a great deal more research needs to be done and the variables need to be narrowed to be accurate,” asserts Dr. Brill.

   Dr. Le notes that she and the Undersea and Hyperbaric Medical Society agree with the study authors that physicians should use HBOT as a part of the overall strategy in healing recalcitrant diabetic foot ulcers rather than as a single agent to completely heal those wounds. She cites AHA Level 1A evidence that hyperbaric oxygen is efficacious as adjunctive therapy for the healing of diabetic foot ulcers. Dr. Le cautions that due to variability in practitioner utilization of HBOT, the results of this study cannot be generalized to wound care or hyperbaric medicine practices nationally.

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