Hyperbaric Oxygenation in Diabetic Ulcer

Diabetes Mellitus Clinical Trial

Official title:

Hyperbaric Oxygenation (HBO) in Chronic Diabetic Leg Ulcer.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02042339
• Other study ID #: 24-265ex11/12
• Secondary ID: 2012-001436-57
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2019
• Est. completion date: December 2022

Study information

• Verified date: May 2019
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diabetes mellitus

• Age between 18 and 80 years

• Chronic foot ulcer (up to Wagner scale III)

• Patency of large vessels tributary to region of wound

• Good outpatient diabetes management as verified by a specialized centre (HbA1c<8.5%; IFCC: 69mmol/mol).

Exclusion Criteria:

• Clinically relevant obstruction of large vessels tributary to region of wound

• Non-adherence to diabetes therapy

• Pregnancy

• Reactive airway disease

• Radiographic evidence of pulmonary blebs or bullae

• Untreated pneumothorax

• History of seizures except childhood febrile seizures

• Cardiovascular instability

• Mechanical ventilator support

• Treatment with Bleomycin or Anthracyclin in history

• Unable to perform the Valsalva-procedure

• Participation as a subject in any other medical or biomedical research project; if previously involved as a subject, sufficient time must have elapsed to permit "wash out" of any investigational agent.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Austria	Division of Thoracic and Hyperbaric Surgery	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (3)

Kranke P, Bennett MH, Martyn-St James M, Schnabel A, Debus SE. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD004123. doi: 10.1002/14651858.CD004123.pub3. Review. Update in: Cochrane Database Syst Rev. 2015;(6) — View Citation

Löndahl M. Hyperbaric oxygen therapy as adjunctive treatment of diabetic foot ulcers. Med Clin North Am. 2013 Sep;97(5):957-80. doi: 10.1016/j.mcna.2013.04.004. Epub 2013 Jul 6. Review. — View Citation

O'Reilly D, Pasricha A, Campbell K, Burke N, Assasi N, Bowen JM, Tarride JE, Goeree R. Hyperbaric oxygen therapy for diabetic ulcers: systematic review and meta-analysis. Int J Technol Assess Health Care. 2013 Jul;29(3):269-81. doi: 10.1017/S0266462313000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endothelial progenitor cells	Modulation of number	Weeks 1-6, Months 3,6,12
Primary	ICG (indocyanine green) video angiography	Change in ICG-adsorption measured by ICG video angiography from baseline to week/month xxx	Weeks 1-3, 6; Months 3, 6, 12
Secondary	High performance 3D LifeViz™ system	Change of size/configuration of wound from baseline to week/month xxx	Week 1-6; Months 3, 6, 12

External Links

•   The Division of Thoracic and Hyperbaric Surgery is part of the Medical University Graz