Status:

COMPLETED

Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Lead Sponsor:

Assaf-Harofeh Medical Center

Conditions:

Diabetic Foot Ulcers

Eligibility:

All Genders

18+ years

Phase:

NA

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 ti...

Eligibility Criteria

Inclusion

  • diabetic patients, aged 18 years or older, with non-healing foot ulcers

Exclusion

  • 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.

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

End Date :

September 1 2005

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00463671

Start Date

December 1 2003

End Date

September 1 2005

Last Update

October 17 2008

Active Locations (1)

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1

The Institute of Hyperbaric Medicine and Wound Care Clinic

Ẕerifin, Israel, 70300