Topical hyperbaric oxygen and low-energy laser for the treatment of chronic ulcers.
BACKGROUND: Diabetic foot ulcers (DFU) and chronic venous ulcers (CVU) are persistent cutaneous lesions that are difficult to treat and heal. Topical hyperbaric oxygen (THO) and low-energy laser (LEL) are therapies that have been employed separately for ulcer treatment, but their concomitant use has not been investigated. METHODS: In this unblinded, open-label non-randomized trial, we treated 374 consecutive patients with treatment-refractory chronic ulcers (218 patients with DFU and 156 individuals with CVU) with a combination of THO and LEL. THO was administered by pumping 100% oxygen into a disposable, sealed polyethylene chamber for 2 h, two to three times weekly. LEL was administered concurrently using a helium-neon laser at 4 J/cm(2) for 20 min. RESULTS: Complete ulcer closure was obtained in 78% of patients in each group (170 patients with DFU and 127 patients with CVU). Treatment failure resulting in amputation in DFU was seen in 48 patients (22%); non-closure of ulcers within 18 months in individuals with CVU was seen in 29 (22%). The length of therapy was also similar in the two groups (3.7+/-3 versus 4.1+/-3 months in DFU and CVU cohorts, respectively). However, the number of treatments required to affect healing was greater in the CVU group than among the DFU patients (40+/-25 versus 31.4+/-20 treatments). CONCLUSION: THO and LEL therapies are safe, effective, simple and inexpensive therapies for DFU and CVU. Confirmation must await the performance of double-blind, randomized, controlled trials currently under way.