SLR - September 2010 - Sarah Elder
Reference: Londahl, M, Nilsoon, A, Katzman, P, & Hammablund, C. (2010). Hyperbaric Oxygen Therapy Facilitates Healing of Chronic Foot Ulcers in Patients with Diabetes. Diabetes Care, 33 (5), 998-1003.
Scientific Literature Reviews
Reviewed by: Sarah Elder, DPM
Residency Program: Beth Israel Deaconess Medical Center
Podiatric Relevance:
The treatment of chronic diabetic foot ulcerations is often complex. A myriad of treatments have been proposed to accelerate the healing rate of diabetic foot ulcers. Hyperbaric oxygen is a modality that is incorporated in many wound care centers and hospitals to expedite wound healing rates. This study is a randomized, single-center, prospective, placebo-controlled study evaluating the effectiveness of hyperbaric oxygen therapy on diabetic foot ulcerations.
Methods:
94 patients with Wagner grades 2 through 4 ulcerations present for over 3 months were enrolled in a randomized, single-center, double-blinded, placebo-controlled trial comparing hyperbaric oxygen therapy (HBOT) to hyperbaric air therapy (placebo). These patients were treated in a hyperbaric chamber for 85 minutes daily for 8 weeks. Statistical data was calculated for all patients originally fulfilling medical inclusion criteria (intention-to-treat analysis), and those patients completing over 35 sessions (per-protocol analysis). All patients enrolled in the study either had adequte distal perfusion or nonreconstructable peripheral vascular disease, and all patients were free of acute infection.
Results:
94 patients that fit the above criteria were randomized into either the HBOT or placebo groups, and these 94 patients were included in the intention-to-treat group. Of the 94 patients, 75 patients underwent more than 35 treatment sessions (per-protocol). The healing of Wagner grade 2 and 3 ulcerations was indicated by epithelial regeneration of the index ulcer for two consecutive visits. Wagner grade 4 ulcerations were considered healed when the gangrene had separated and the ulcer had a new epithelial covering. The patients were tracked for one year. In the intention-to-treat group analysis, complete healing of the ulcer was achieved in 25/48 patients (52%) in the HOBT and 12/42 (29%) in the placebo group. In the per-protocol group, complete healing of the ulcer occurred in 23/38 (61%) in the HBOT group and 10/37 (27%) in the placebo group.
Conclusion:
The findings in this study show that adjunctive treatment with HBOT can help to promote healing of chronic diabetic foot ulcerations. In both the per-protocol and intention-to-treat groups, patients receiving the hyperbaric oxygen had statistically significant higher healing rates than those receiving the placebo air treatment. The findings in this study may help to facilitate the use of hyperbaric oxygen treatment for chronic diabetic foot ulcerations by more podiatrists.