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Hyperbaric Oxygenation in Diabetic Ulcer

Primary Purpose

Diabetes Mellitus

Status
Unknown status
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Hyperbaric oxygen
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Hyperbaric Oxygen, Diabetic ulcer, Wound healing, 3-D life-viz- system, Indocyanine green video angiography, Transcutaneous oxygen pressure, Endothelial progenitor cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Division of Thoracic and Hyperbaric Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hyperbaric oxygen

Sham Hyperbaric oxygen

Arm Description

Problem-wound schedule: 2.4 atmospheres, 100% oxygen for 90 minutes, two 10 - minute breaks (patients breathing pressurized air from the chamber atmosphere)

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

High performance 3D LifeViz™ system
Change of size/configuration of wound from baseline to week/month xxx

Full Information

First Posted
January 20, 2014
Last Updated
May 17, 2019
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT02042339
Brief Title
Hyperbaric Oxygenation in Diabetic Ulcer
Official Title
Hyperbaric Oxygenation (HBO) in Chronic Diabetic Leg Ulcer.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Hyperbaric Oxygen, Diabetic ulcer, Wound healing, 3-D life-viz- system, Indocyanine green video angiography, Transcutaneous oxygen pressure, Endothelial progenitor cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric oxygen
Arm Type
Experimental
Arm Description
Problem-wound schedule: 2.4 atmospheres, 100% oxygen for 90 minutes, two 10 - minute breaks (patients breathing pressurized air from the chamber atmosphere)
Arm Title
Sham Hyperbaric oxygen
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen
Other Intervention Name(s)
HBO, Hyperbaric oxygenation
Intervention Description
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.
Primary Outcome Measure Information:
Title
ICG (indocyanine green) video angiography
Description
Change in ICG-adsorption measured by ICG video angiography from baseline to week/month xxx
Time Frame
Weeks 1-3, 6; Months 3, 6, 12
Secondary Outcome Measure Information:
Title
High performance 3D LifeViz™ system
Description
Change of size/configuration of wound from baseline to week/month xxx
Time Frame
Week 1-6; Months 3, 6, 12
Other Pre-specified Outcome Measures:
Title
Endothelial progenitor cells
Description
Modulation of number
Time Frame
Weeks 1-6, Months 3,6,12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freyja M Smolle-Juettner, M.D.
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Thoracic and Hyperbaric Surgery
City
Graz
State/Province
Styria
ZIP/Postal Code
A-8036
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freyja M Smolle-Juettner, M.D.
Phone
0043-316-385
Ext
13302
Email
freyja.smolle@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Lars P Kamolz, M.D.
Phone
0043-316-385
Ext
82819
Email
lars.kamolz@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Freyja M Smolle-Juettner, M.D.
First Name & Middle Initial & Last Name & Degree
Lars P Kamolz, M.D.
First Name & Middle Initial & Last Name & Degree
Michael Schintler, M.D.
First Name & Middle Initial & Last Name & Degree
Barbara Obermayer-Pietsch, M.D.
First Name & Middle Initial & Last Name & Degree
Gerd Koehler, M.D.
First Name & Middle Initial & Last Name & Degree
Gerlies Bock, M.D.
First Name & Middle Initial & Last Name & Degree
Joerg Lindenmann, M.D.
First Name & Middle Initial & Last Name & Degree
Nicole Neuboeck, M.D.
First Name & Middle Initial & Last Name & Degree
Christian Porubsky, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
23863187
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/S0266462313000263.
Results Reference
result
PubMed Identifier
23992903
Citation
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.
Results Reference
result
PubMed Identifier
22513920
Citation
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.
Results Reference
result
Links:
URL
http://www.medunigraz.at/
Description
The Division of Thoracic and Hyperbaric Surgery is part of the Medical University Graz

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Hyperbaric Oxygenation in Diabetic Ulcer

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