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Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Diabetic Foot Ulcers Clinical Trial

Official title:
The Relation Between Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation in Diabetic Patients Suffering From Foot Ulcers

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00463671
Study type Interventional
Source Assaf-Harofeh Medical Center
Contact
Status Completed
Phase N/A
Start date December 2003
Completion date September 2005
View Details
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