Effects of the prolonged administration of N-acetylcysteine on tissutal oxigenation and healing of foot ulcers in diabetic patients. - ND
Active, not recruiting
- Conditions
- Diabetes mellitus complicated by foot ulcer.MedDRA version: 9.1Level: LLTClassification code 10012664Term: Diabetic foot ulcer
- Registration Number
- EUCTR2009-010418-31-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age between 45 and 70 years.
Type 1 or 2 Diabetes mellitus.
Foot ulcer Grade 1A (Texas University classification) (Group A)
Chronic foot ulcer for at least 1 year (group B).
Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Age < 45 or > 75 years.
N-acetylcysteine assumption in the 6 months previous to the study.
Hypersensitivity to acetylcysteine.
Neoplasms or severe systemic, hepatic, pulmonary, cardiovascolar or renal diseases.
Psychiatric disorders, alcohol or drugs abuse.
Written informed consent absence.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Improvement of the tissue oxygenation<br>Ulcer healing;Secondary Objective: Increase of NO bioavailability<br>Reduction of the oxidative status<br>Reduction of endothelial activation;Primary end point(s): Improvement of the tissue oxygenation<br>Ulcer healing
- Secondary Outcome Measures
Name Time Method