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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
The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.
Topical hyperbaric oxygen and low-energy laser treatment
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