Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation
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|ClinicalTrials.gov Identifier: NCT00463671|
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : October 17, 2008
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|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00463671
|The Institute of Hyperbaric Medicine and Wound Care Clinic|
|Zerifin, Israel, 70300|
|Principal Investigator:||Shai Efrati, MD||Assaf-Harofeh Medical Center|