NCT00463671

Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DRUG	N-acetylcysteine

Timeline

• Start date: 2003-12-01
• Completion: 2005-09-01
• First posted: 2007-04-20
• Last updated: 2008-10-17

Locations

1 site across 1 country: Israel