Hyperbaric Oxygenation in Diabetic Ulcer

Summary

Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in an increase of total oxygen in the body. The elevated tissue levels of oxygen may persist for hours, instigating healing processes in wounds caused by disturbances in of perfusion in small vessels, a condition often found in patient with diabetes. We plan a prospective, double-blind randomized clinical study in 80 patients with chronic diabetic ulcer. All will have optimum treatment of diabetes. The HBO group will be given HBO at 2.4 bar, 90 min., 30 sessions, controls will have sham HBO. Routine wound care will be identical in both groups. Before, during and after treatment (3, 6 and 12 months), a number of monitoring and imaging procedures will be done, cells in the bloodstream indicating improved healing will be determined. Hypothesis: HBO will instigate the healing process in the majority of patients with chronic diabetic leg ulcer, provided the patency of the large vessels is given.

Timeline

Start

2019-12

Primary completion

2021-12

Completion

2022-12

Publications

• Results O'Reilly D, Pasricha A, Campbell K, Burke N, Assasi N, Bowen JM, Tarride JE, Goeree R. Hyperbaric oxygen therapy for diabetic ulcers: systematic review and meta-analysis. Int J Technol Assess Health Care. 2013 Jul;29(3):269-81. doi: 10.1017/S0266462313000263.
• Results Londahl M. Hyperbaric oxygen therapy as adjunctive treatment of diabetic foot ulcers. Med Clin North Am. 2013 Sep;97(5):957-80. doi: 10.1016/j.mcna.2013.04.004. Epub 2013 Jul 6.
• Results Kranke P, Bennett MH, Martyn-St James M, Schnabel A, Debus SE. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD004123. doi: 10.1002/14651858.CD004123.pub3.

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