Diabetes mellitus complicated by foot ulcer. MedDRA version: 9.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer
Conditions
Interventions
Trade Name: FLUIMUCIL*20CPR EFF 600MG
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: Acetylcysteine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of the tissue oxygenation Ulcer healing;Secondary Objective: Increase of NO bioavailability Reduction of the oxidative status Reduction of endothelial activation;Primary end point(s): Improvement of the tissue oxygenation Ulcer healing | — |
Countries
Italy
Outcome results
None listed