While there is not an overwhelming amount of literature on hyperbaric oxygen therapy (HBO), the recent decision by the Centers for Medicare and Medicaid Services (CMS) to cover the use of HBO in treating diabetic foot wounds has fueled new discussions on the potential efficacy of the modality. With this in mind, our panelists discuss their experiences in using HBO, the current literature on the subject and reimbursement issues. Q: What has been your experience in using hyperbaric oxygen therapy (HBO) to treat lower extremity wounds? A: Leon Brill, DPM, says he has had a “very positive” experience using HBO within his group practice setting. Dr. Brill was involved in a 33-month retrospective study of patients with diabetic foot ulcers. He says this study consisted of 87 patients who received HBO in addition to standard wound care and 382 patients who received only standard wound care. Dr. Brill notes the limb salvage rate for the HBO patients was 72 percent in comparison to the 53 percent salvage rate for those who received standard wound care. Steven Kominsky, DPM, who has used HBO in 100 cases over a 20-year period, says he has been pleased with the results he has seen. “Many ‘non-salvageable’ extremities have healed with the use of hyperbaric oxygen and meticulous wound care,” notes Dr. Kominsky. Ronald Sage, DPM, says he has had limited experience with the modality as he has only used HBO to treat five or six patients with diabetes over the past 10 years. These patients had Wagner Grade III foot ulcers, severe peripheral vascular disease and long-term non-healing. Dr. Sage says half of the patients had successful healing with HBO while the other half went on to amputation. Drs. Brill and Kominsky agree that appropriate patient selection is the key to success in using HBO. Dr. Brill emphasizes that he reserves the modality for a select group of patients whom he feels are at a high risk of limb loss. These patients include those who have necrotizing fasciitis, chronic osteomyelitis and threatened flaps from various types of amputations as well as peripheral vascular disease cases that are not reconstructable. When the patient’s pulses are strong and he or she has a well-perfused limb, HBO is unnecessary, according to Dr. Kominsky. He has found that HBO is most effective for treating those who have marginal circulation. Dr. Kominsky adds that obtaining non-invasive vascular studies, including transcutaneous oxygen measurements, can help you determine the patient’s healing potential. When it comes to HBO, David Armstrong, DPM, says he has seen the best outcomes when he has used it as an antibiotic after performing emergent debridement of a severe limb- or life-threatening infection. In his experience, Dr. Armstrong has found that eight to 10 dives of HBO over a four to five-day period has appeared to be beneficial. Dr. Sage says HBO treatments are typically performed for 90 minutes a day for approximately 30 days, depending upon the patient’s progress. He notes that he reserves HBO for patients with significant peripheral vascular disease who have failed four to six weeks of standard wound care and had an unsuccessful bypass or are not bypass candidates. Dr. Armstrong also notes that he has generally used HBO to help treat patients who have severe peripheral occlusive disease but are not bypass candidates. However, Dr. Armstrong notes, that “for my health care dollar, I often prefer a distal bypass for a bypass candidate rather than a six-week course of HBO, if at all possible.” Q: Are there any prospective pivotal studies that prove HBO is more effective than placebo? A: Dr. Brill says there are no pivotal studies that demonstrate the efficacy of HBO. Having conducted a prospective trial on HBO, Dr. Brill points out that it is a “very difficult” process and difficulties in trial design have contributed to the lack of pivotal evidence on this modality. However, Dr. Brill says there is compelling evidence that HBO does have a beneficial effect. Last year. Medicare published a decision memorandum regarding the coverage of HBO and Dr. Brill says this document provides a good synopsis of the HBO studies that have been conducted so far. However, he does caution that there are major flaws such as comparability of patients, treatment bias and the inability to adequately blind the studies.