Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcers

• Registration Number: NCT00463671
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2005-09
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-18
• Study First Posted: 2007-04-20
• Status Verified: 2007-05
• Last Update Submitted: 2008-10-16
• Last Update Posted: 2008-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Institute of Hyperbaric Medicine and Wound Care Clinic; 🇮🇱 Zerifin, Israel