Effects of N-acetylcysteine on Diabetic Foot Oxygenation
- Registration Number
- NCT01082445
- Lead Sponsor
- University of Turin, Italy
- Brief Summary
The purpose of this study is to determine whether N-acetylcysteine is effective in the treatment or prevention of the foot ulcers in diabetic patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Age between 45 and 70 years.
- Type 1 or 2 diabetes mellitus with foot ulcer (grade 0 stage C according to Texas University Classification).
- Written informed consent.
Exclusion Criteria
- N-acetylcysteine assumption in the 6 months previous to the study.
- Hypersensibility to acetylcysteine.
- Neoplasms, severe systemic, hepatic, pulmonary, cardiovascular or renal diseases.
- Psychiatric diseases or drug abuse problems.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description N-acetylcysteine N-acetylcysteine 50 patients that receive 600 mg of acetylcysteine for 3 times a day. Placebo Placebo 50 subjects taking placebo pills 3 times a day
- Primary Outcome Measures
Name Time Method Tissue oxygenation improvement Basal (time 0) and after 3 months of treatment/observation
- Secondary Outcome Measures
Name Time Method Improvement of the endothelial function Basal (time 0) and after 3 months of treatment/observation nitrites/nitrates - ICAM - VCAM - PAI-1
Oxidation status reduction Basal (time 0) and after 3 months of treatment/observation 8-iso PGF-2alpha assessment
Trial Locations
- Locations (1)
Div. Endocrinology, Diabetology and Metabolism - University of Turin
🇮🇹Turin, TO, Italy