Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation
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Purpose
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 | Intervention |
|---|---|
|
Diabetic Foot Ulcers |
Drug: N-acetylcysteine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: 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 |
- 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2003 |
| Study Completion Date: | September 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Israel | |
| The Institute of Hyperbaric Medicine and Wound Care Clinic | |
| Zerifin, Israel, 70300 | |
| Principal Investigator: | Shai Efrati, MD | Assaf-Harofeh Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00463671 History of Changes |
| Other Study ID Numbers: | HBO2/03 |
| Study First Received: | April 18, 2007 |
| Last Updated: | October 16, 2008 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Ulcer Foot Ulcer Diabetic Foot Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
Acetylcysteine N-monoacetylcystine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on May 23, 2013