Foot Ulcer, Diabetic
Conditions
Keywords
stage C, grade 0 (Texas University)
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.
Interventions
DRUGN-acetylcysteine
600 mg, 1 tablet 3 times a day for 3 months
DRUGPlacebo
Placebo
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tissue oxygenation improvement | Basal (time 0) and after 3 months of treatment/observation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed