NCT02042339

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Timeline
Completed

Started Dec 2019

Typical duration for phase_3 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
5.9 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

January 20, 2014

Last Update Submit

May 17, 2019

Conditions

Diabetes Mellitus

Keywords

Hyperbaric OxygenDiabetic ulcerWound healing3-D life-viz- systemIndocyanine green video angiographyTranscutaneous oxygen pressureEndothelial progenitor cells

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • High performance 3D LifeViz™ system

    Week 1-6; Months 3, 6, 12

Other Outcomes (1)

  • Endothelial progenitor cells

    Weeks 1-6, Months 3,6,12

Study Arms (2)

Hyperbaric oxygen

EXPERIMENTAL

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

Sham Hyperbaric oxygen

PLACEBO COMPARATOR

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

Interventions

Hyperbaric oxygenDRUG

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.

Also known as: HBO, Hyperbaric oxygenation
Hyperbaric oxygenSham Hyperbaric oxygen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Thoracic and Hyperbaric Surgery

Graz, Styria, A-8036, Austria

Location

Related Publications (3)

  • 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.

    PMID: 23863187RESULT

  • 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.

    PMID: 23992903RESULT

  • 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.

    PMID: 22513920RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Freyja M Smolle-Juettner, M.D.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 22, 2014

Study Start

December 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

AU(1)