Lack of effectiveness of hyperbaric oxygen therapy for the treatment of diabetic foot ulcer and the prevention of amputation: a cohort study.

Abstract

OBJECTIVE:

Hyperbaric oxygen (HBO) is a device that is used to treat foot ulcers. The study goal was to compare the effectiveness of HBO with other conventional therapies administered in a wound care network for the treatment of a diabetic foot ulcer and prevention of lower-extremity amputation.

RESEARCH DESIGN AND METHODS:

This was a longitudinal observational cohort study. To address treatment selection bias, we used propensity scores to determine the "propensity" that an individual was selected to receive HBO.

RESULTS:

We studied 6,259 individuals with diabetes, adequate lower limb arterial perfusion, and foot ulcer extending through the dermis, representing 767,060 person-days of wound care. In the propensity score-adjusted models, individuals receiving HBO were less likely to have healing of their foot ulcer (hazard ratio 0.68 [95% CI 0.63-0.73]) and more likely to have an amputation (2.37 [1.84-3.04]). Additional analyses, including the use of an instrumental variable, were conducted to assess the robustness of our results to unmeasured confounding. HBO was not found to improve the likelihood that a wound might heal or to decrease the likelihood of amputation in any of these analyses.

CONCLUSIONS:

Use of HBO neither improved the likelihood that a wound would heal nor prevented amputation in a cohort of patients defined by Centers for Medicare and Medicaid Services eligibility criteria. The usefulness of HBO in the treatment of diabetic foot ulcers needs to be reevaluated.

• Authors: David J Margolis, Jayanta Gupta, Ole Hoffstad, Maryte Papdopoulos, Henry A Glick, Stephen R Thom, Nandita Mitra
• Journal: Diabetes care (Diabetes Care) Vol. 36 Issue 7 Pg. 1961-6 (Jul 2013) ISSN: 1935-5548 [Electronic] United States
• PMID: 23423696 (Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, P.H.S.)

Topics

• Adult
• Aged
• Aged, 80 and over
• Amputation, Surgical (statistics & numerical data)
• Diabetic Foot (surgery, therapy)
• Female
• Humans
• Hyperbaric Oxygenation
• Longitudinal Studies
• Male
• Middle Aged
• Treatment Outcome