Clinical Trial – Hyperbaric Oxygenation in Diabetic Ulcer

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.

[Prevention of diabetic foot].

Abstract: Diabetic foot (DF) is the most common chronic complication, which depends mostly on the duration and successful treatment of diabetes mellitus. Based on epidemiological studies, it is estimated that 25% of persons with diabetes mellitus (PwDM) will develop...

Hyperbaric oxygen for chronic wounds.

Abstract: Hyperbaric oxygen therapy (HBOT), the administration of pressurized 100% oxygen, is used as an adjunct to aid healing in selected chronic wounds. Though the therapy has had a controversial history, research is now elucidating the mechanisms by which HBOT...