Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00463671
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : October 17, 2008
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct therapy for diabetic wounds. However, some patients have insufficient increase or even paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was to investigate the pathophysiology responsible for the different consequences of HBOT and to evaluate the effect of N-acetylcysteine (NAC) on these changes.

Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide (NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete HBOT protocol.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Drug: N-acetylcysteine Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Relation Between Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation in Diabetic Patients Suffering From Foot Ulcers
Study Start Date : December 2003
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The aim of the present study was to investigate whether changes in oxidative stress and NO bioavailability are responsible for the different effects of HBOT on tissue oxygenation in diabetic patients suffering from foot ulcers.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diabetic patients, aged 18 years or older, with non-healing foot ulcers

Exclusion Criteria:

  • Patients with macrovascular disease amenable for revascularization with more than 70% obstruction in femoral artery (evaluated by US doppler) were excluded from the study. Similarly, patients with a documented allergy to NAC, liver cirrhosis or those receiving NAC for other indications were excluded. Finally, patients with chest pathology incompatible with pressure changes, patients with inner ear disease, or those suffering from claustrophobia were excluded.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00463671

The Institute of Hyperbaric Medicine and Wound Care Clinic
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Shai Efrati, MD Assaf-Harofeh Medical Center Identifier: NCT00463671     History of Changes
Other Study ID Numbers: HBO2/03
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: May 2007

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs