Effects of N-acetylcysteine on Diabetic Foot Oxygenation

University of Turin, Italy100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Foot Ulcer, Diabetic

Interventions

N-acetylcysteineDRUG

600 mg, 1 tablet 3 times a day for 3 months

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Div. Endocrinology, Diabetology and Metabolism - University of Turin

Turin, TO, Italy

Outcomes

Primary Outcomes

Tissue oxygenation improvement

Time frame: Basal (time 0) and after 3 months of treatment/observation

Secondary Outcomes

Improvement of the endothelial function

nitrites/nitrates - ICAM - VCAM - PAI-1

Time frame: Basal (time 0) and after 3 months of treatment/observation

Oxidation status reduction

8-iso PGF-2alpha assessment

Time frame: Basal (time 0) and after 3 months of treatment/observation

Data from ClinicalTrials.gov

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