Chronic foot ulcers are common in long-standing diabetes, may herald severe complications and are often resistant to therapy. To evaluate the effects of adjunctive topical hyperbaric oxygen treatment (THBO) and low energy laser (LEL) irradiation on ulcer healing, a 100 consecutive patients with chronic diabetic foot ulcers (DFU) refractory to 4.5 +/- 1.2 months of comprehensive treatment, were enrolled in a prospective open study. While conventional treatment was continued as necessary, THBO was administered by pumping 100 percent oxygen into a disposable sealed polythylene hyperbaric chamber (150 min x 2 to 3/wk at up to 1.04 atm). Helium-neon LEL irradiation was given concurrently using a Unilaser Scan Unit at 4 J/cm2 for 20 min. Some patients continued THBO at home or their treatment was confined to THBO at home. Patients were monitored every two weeks revealing 81 percent cure after 25 +/- 13 treatments over 3.2 +/- 1.7 months. On follow-up (median 18 months), only 3/81 (4 percent) had reulceration, which responded to THBO/LEL retreatment. Nonresponders had significantly lower ankle brachial indices (ABI) than patients whose ulcers were healed (0.55 vs. 0.78, p < 0.01) and ultimately required amputation. Patient compliance was full and no adverse events occurred. In conclusion, although the study was open and uncontrolled, an 81 percent healing of DFU in patients who previously did not respond to a comprehensive treatment program, constitutes an intriguing preliminary result. Thus, THBO/LEL therapy may be a safe, simple, and inexpensive early adjunctive treatment for patients with chronic diabetic foot ulcers. Our findings should prompt its evaluation by large randomized controlled trials.
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