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Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Primary Purpose

Diabetic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Institute of Hyperbaric Medicine and Wound Care Clinic

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2007
Last Updated
October 16, 2008
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00463671
Brief Title
Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation
Official Title
The Relation Between Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation in Diabetic Patients Suffering From Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Efrati, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute of Hyperbaric Medicine and Wound Care Clinic
City
Zerifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

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Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

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