Trial record 2 of 28 for:    Open Studies | "Hyperbaric Oxygenation"

Hyperbaric Oxygenation in Diabetic Ulcer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT02042339
First received: January 20, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: Hyperbaric oxygen
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Endothelial progenitor cells [ Time Frame: Weeks 1-6, Months 3,6,12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
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)
Arms Assigned Interventions
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.
Other Names:
  • HBO
  • Hyperbaric oxygenation
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042339

Locations
Austria
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    freyja.smolle@medunigraz.at   
Contact: Lars P Kamolz, M.D.    0043-316-385 ext 82819    lars.kamolz@medunigraz.at   
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.         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Freyja M Smolle-Juettner, M.D. Medical University of Graz
  More Information

Additional Information:
Publications:
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02042339     History of Changes
Other Study ID Numbers: 24-265ex11/12, 2012-001436-57
Study First Received: January 20, 2014
Last Updated: January 20, 2014
Health Authority: Austria: Agency for Health and Food Safety
Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Graz:
Hyperbaric Oxygen
Diabetic ulcer
Wound healing
3-D life-viz- system
Indocyanine green video angiography
Transcutaneous oxygen pressure
Endothelial progenitor cells

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014