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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02042339
Study type Interventional
Source Medical University of Graz
Contact
Status Not yet recruiting
Phase Phase 3
Start date December 2019
Completion date December 2022

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