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 Details — Status: Completed

Administrative data

• NCT number: NCT00463671
• Other study ID #: HBO2/03
• Status: Completed
• Phase: N/A
• First received: April 18, 2007
• Last updated: October 16, 2008
• Start date: December 2003
• Est. completion date: September 2005

Study information

• Verified date: May 2007
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer

Intervention

Drug:
• N-acetylcysteine

Locations

Country	Name	City	State
Israel	The Institute of Hyperbaric Medicine and Wound Care Clinic	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.