Diabetes Mellitus Clinical Trial
Official title:
Hyperbaric Oxygenation (HBO) in Chronic Diabetic Leg 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.
We plan a prospective, double-blind randomized clinical study (phase III) in 80 patients with
diabetes mellitus. All of them will receive the optimum metabolic treatment for their
underlying disease. The treatment group will be administered HBO according to the problem
wound schedule, the controls will have sham treatment in the hyperbaric chamber. Routine
wound care (dressings, physiotherapy, antibiotics if necessary) will be identical in both
groups and according to its clinical needs.
Before treatment, indocyanine green videoangiography (ICG), transcutaneous (partial) oxygen
pressure (TcPO2) and LifeViz 3D (three-dimensional medical imaging and reconstruction)
documentation will be done and endothelial progenitor cells (EPC) as well as markers of bone
metabolism will be determined in all patients.
The measurements will be repeated according to the schedule during the treatment period and
at controls after 3, 6 and 12 months.
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