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Diabetes MellitusPhase 3NCT02042339

Hyperbaric Oxygenation in Diabetic Ulcer

A Phase 3 study testing Hyperbaric oxygen in people with Diabetes Mellitus, run by Medical University of Graz at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Hyperbaric oxygen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteAustria
Study dates
Dec 2019to Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Division of Thoracic and Hyperbaric Surgery

    Graz, Styria, A-8036

    Freyja M Smolle-Juettner, M.D., 0043-316-385 ext. 13302, freyja.smolle@medunigraz.at

    Lars P Kamolz, M.D., 0043-316-385 ext. 82819, lars.kamolz@medunigraz.at

Other trials in Austria

About this study

Official title: 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.

Read the 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.

Being tested
Hyperbaric oxygen
Keywords
Hyperbaric Oxygen, Diabetic ulcer, Wound healing, 3-D life-viz- system, Indocyanine green video angiography, Transcutaneous oxygen pressure, Endothelial progenitor cells
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperbaric oxygenDrug

    Also called HBO, Hyperbaric oxygenation

    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.

Study groups in NCT02042339
Study groupRoleWhat they receive
Hyperbaric oxygenExperimentalProblem-wound schedule: 2.4 atmospheres, 100% oxygen for 90 minutes, two 10 - minute breaks (patients breathing pressurized air from the chamber atmosphere)
Receives: Drug: Hyperbaric oxygen
Sham Hyperbaric oxygenPlacebo comparatorThe 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.
Receives: Drug: Hyperbaric oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICG (indocyanine green) video angiography

    Change in ICG-adsorption measured by ICG video angiography from baseline to week/month xxx

    Measured: Weeks 1-3, 6; Months 3, 6, 12

Secondary outcomes (1)

  1. High performance 3D LifeViz™ system

    Change of size/configuration of wound from baseline to week/month xxx

    Measured: Week 1-6; Months 3, 6, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2014 (estimated)
  2. Study startDec 2019 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02042339
Sponsor's protocol ID
24-265ex11/12
Other IDs
2012-001436-57
Status last verified
May 2019
First submitted
20 Jan 2014
Last updated
20 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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/S0266462313000263.

    PubMed 23863187

  • Londahl 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.

    PubMed 23992903

  • 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.

    PubMed 22513920

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hyperbaric oxygen in people with Diabetes Mellitus, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICG (indocyanine green) video angiography (time frame: Weeks 1-3, 6; Months 3, 6, 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02042339, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.

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