Hyperbaric Oxygenation (HBO) in Chronic Diabetic Leg Ulcer.
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.
Condition:
Diabetes Mellitus
Treatment:
Hyperbaric oxygen
Start Date:
December 2019
Sponsor:
Medical University of Graz
For More Information:
https://clinicaltrials.gov/show/NCT02042339