Lack of Effectiveness of Hyperbaric Oxygen Therapy?

http://care.diabetesjournals.org/content/early/2013/02/14/dc12-2160.abstract

Results from a longitudinal cohort study from our colleagues Dave Margolis and coworkers at University of Pennsylvania.
  1. Lack of Effectiveness of Hyperbaric Oxygen Therapy for the Treatment of Diabetic Foot Ulcer and the Prevention of Amputation

    A cohort study

  1. David J. Margolis, MD, PHD1,2,
  2. Jayanta Gupta, MD, PHD2,
  3. Ole Hoffstad, MS2,
  4. Maryte Papdopoulos, BA2,
  5. Henry A. Glick, PHD3,
  6. Stephen R. Thom, MD, PHD4 and
  7. Nandita Mitra, PHD2

+Author Affiliations


  1. 1Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

  2. 2Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

  3. 3Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

  4. 4Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
  1. Corresponding author: David J. Margolis, margo@mail.med.upenn.edu.

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 have healing of their foot ulcer (hazard ratio, 0.68; 95% confidence interval, 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.

David G. Armstrong

Dedicated to amputation prevention, wound healing, diabetic foot, biotechnology and the intersection between medical devices and consumer electronics.

3 comments

  • HBOT is a tool. Every tool can be demonstrated to be effective or useless, depending on the circumstances in which it is employed. From personal observation, it seems to me that many of my colleagues expect that HBO will result in healing without addressing other factors, especially offloading, debridement of infected bone & ensuring adequate tissue oxygenation.

  • Did they include patients who received HBOT and were offloaded or casted vs those centers that allowed the patients to walk on their feet during therapy? Be careful what you read.

  • The other consideration is when HBOt is initiated. Often the patients that do receive HBOt are given treatment only after all other options have been exhausted. From personal experience, patients that start HBOt prior to extended non-successful care have a greater likelihood of healing and at least remaining in “ulcer remission” for longer periods of time. Earlier referral and subsequent therapy may help prevent many of these patients from ending up in HBOt as a “last resort”?

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