Cath Lab Digest

  With regard to the article on topical oxygen (Blackman E, Moore C, Hyatt J, Railton R, Frye C. Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: a prospective controlled study. Ostomy Wound Manage. 2010;56(6):24–31), I am concerned that a nonrandomized, nonblinded trial was published in your journal. The results are meaningless in my practice, especially so because the study was paid for by the manufacturer.

  This paper will be quoted by third-party payors wanting to refuse hyperbaric oxygen therapy. This is a shame because the scientific basis for this publication is so scanty.

   Eugene R. Worth, MD

Reply

  Dr. Worth’s concerns are understandable. Clearly, randomized double-blind, clinical trials are the gold standard in health-related research. However, when studying medical devices, it is often impractical or unethical to implement a control treatment that mimics the test product for the purposes of blinding.¹ In the case of topical wound oxygen (TWO2) it would be ethical and accomplished with blinded assessment of endpoints by a third-party evaluator, which is the approach that will be employed in future trials.

  A simple search of PubMed using the terms hyperbaric oxygen therapy wound reveals more than 2,000 published studies.² However, in 2004 Kranke et al³ published a systematic review on hyperbaric oxygen (HBO) and chronic wounds, restricting the search to randomized controlled trials (RCTs); only four trials were identified (involving a total number of 147 patients and diabetic ulcers) and just one was double-blinded (16 patients).⁴

  As for a medical and scientific discussion, the publication of nonrandomized trials is important (and also extensively used for HBO as demonstrated above). We don’t question the clear demand for well-designed RCTs but also feel that neglecting observational studies clearly limits innovation and new approaches.⁵ We identified 27 studies reporting positive results using TWO2 on a variety of chronic wounds. The reported study certainly has limitations, which are discussed within the manuscript, but it is the first controlled study on topical oxygen and diabetic ulcers and certainly adds to the knowledge base of TWO2. Most importantly, as a pilot trial, it provided the information needed to design a robust randomized controlled clinical trial protocol, which we will be utilizing in a number of upcoming studies. In summary, we believe that our results are notable and worth publishing.

  Support of this study by the manufacturer was limited to the topical oxygen devices and the oxygen only.

  We believe that TWO2 offers substantial benefits to patients with diabetic ulcers, especially if these patients have contraindications to be treated in full-body HBO chambers. In addition, a new single-use version of this cyclical pressure TWO2 device was launched this month, allowing for these patients to be treated at home.

  In the USA, TWO2 products are marketed by PRO2MED Inc. (www.pro2med.com). We invite Dr. Worth to test the TWO2 device on his patients by utilizing a no-cost, 3-week, risk-free trial offered by this company. Currently payors in the US are starting to acknowledge the benefits of TWO2 — reimbursement is currently in place throughout the Veterans Administration and Indian Health Service and within the MEDICAID segments in New York and Maryland.

   Christian Frye MD, MPH

This article was not subject to the Ostomy Wound Management peer-review process.