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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Hyperbaric Oxygenation (HBO) in Chronic Diabetic Leg Ulcer.|
- ICG (indocyanine green) video angiography [ Time Frame: Weeks 1-3, 6; Months 3, 6, 12 ] [ Designated as safety issue: No ]Change in ICG-adsorption measured by ICG video angiography from baseline to week/month xxx
- High performance 3D LifeViz™ system [ Time Frame: Week 1-6; Months 3, 6, 12 ] [ Designated as safety issue: No ]Change of size/configuration of wound from baseline to week/month xxx
- Endothelial progenitor cells [ Time Frame: Weeks 1-6, Months 3,6,12 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Hyperbaric oxygen
Problem-wound schedule: 2.4 atmospheres, 100% oxygen for 90 minutes, two 10 - minute breaks (patients breathing pressurized air from the chamber atmosphere)
Drug: Hyperbaric oxygen
The treatment will be applied in a large walk-in drive-in hyperbaric chamber. Depending on their general condition, the patients will sit in comfortable chairs or remain in their own wheelchair or bed in relaxed position. They will be accompanied by a medical attendant or by a hyperbaric physician if necessary due to their general condition. Oxygen 100% will be distributed over a tight fitting oxygen-mask connected to the overboard-dumping system. The treatment will be administered according to the so-called problem-wound schedule once a day for six consecutive weeks. On weekends and on public holidays the patients will be off therapy.
Placebo Comparator: Sham Hyperbaric oxygen
The patients will be transferred into the chamber like the treatment group. Instead of 100% oxygen they will breathe normal air through the tight fitting masks, at an ambient pressure of 1.1 bar. During the two 10 - minute breaks patients will breathe pressurized air from the chamber atmosphere.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02042339
|Division of Thoracic and Hyperbaric Surgery||Not yet recruiting|
|Graz, Styria, Austria, A-8036|
|Contact: Freyja M Smolle-Juettner, M.D. 0043-316-385 ext 13302 email@example.com|
|Contact: Lars P Kamolz, M.D. 0043-316-385 ext 82819 firstname.lastname@example.org|
|Principal Investigator: Freyja M Smolle-Juettner, M.D.|
|Sub-Investigator: Lars P Kamolz, M.D.|
|Sub-Investigator: Michael Schintler, M.D.|
|Sub-Investigator: Barbara Obermayer-Pietsch, M.D.|
|Sub-Investigator: Gerd Koehler, M.D.|
|Sub-Investigator: Gerlies Bock, M.D.|
|Sub-Investigator: Joerg Lindenmann, M.D.|
|Sub-Investigator: Nicole Neuboeck, M.D.|
|Sub-Investigator: Christian Porubsky, M.D.|
|Principal Investigator:||Freyja M Smolle-Juettner, M.D.||Medical University of Graz|