Hyperbaric Oxygenation in Diabetic Ulcer

May 17, 2019 updated by: Medical University of Graz

Hyperbaric Oxygenation (HBO) in Chronic Diabetic Leg 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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, A-8036
        • Division of Thoracic and Hyperbaric Surgery
        • Contact:
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICG (indocyanine green) video angiography
Time Frame: Weeks 1-3, 6; Months 3, 6, 12
Change in ICG-adsorption measured by ICG video angiography from baseline to week/month xxx
Weeks 1-3, 6; Months 3, 6, 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High performance 3D LifeViz™ system
Time Frame: Week 1-6; Months 3, 6, 12
Change of size/configuration of wound from baseline to week/month xxx
Week 1-6; Months 3, 6, 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial progenitor cells
Time Frame: Weeks 1-6, Months 3,6,12
Modulation of number
Weeks 1-6, Months 3,6,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Freyja M Smolle-Juettner, M.D., Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-265ex11/12
  • 2012-001436-57 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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