Effects of N-acetylcysteine on Diabetic Foot Oxygenation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valentino Martina, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01082445
First received: March 4, 2010
Last updated: March 7, 2012
Last verified: March 2012

March 4, 2010
March 7, 2012
August 2009
November 2010   (final data collection date for primary outcome measure)
Tissue oxygenation improvement [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01082445 on ClinicalTrials.gov Archive Site
  • Improvement of the endothelial function [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ] [ Designated as safety issue: No ]
    nitrites/nitrates - ICAM - VCAM - PAI-1
  • Oxidation status reduction [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ] [ Designated as safety issue: No ]
    8-iso PGF-2alpha assessment
  • Improvement of the endothelial function [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ] [ Designated as safety issue: No ]
    ICAM - VCAM - PAI-1 - e-Selectin - Intima-media thickness assessment
  • Oxidation status reduction [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ] [ Designated as safety issue: No ]
    8-iso PGF-2alpha assessment
Not Provided
Not Provided
 
Effects of N-acetylcysteine on Diabetic Foot Oxygenation
Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Foot Ulcer, Diabetic
  • Drug: N-acetylcysteine
    600 mg, 1 tablet 3 times a day for 3 months
    Other Name: Fluimucil (R) 600 mg, tablets
  • Drug: Placebo
    Placebo
  • Experimental: N-acetylcysteine
    50 patients that receive 600 mg of acetylcysteine for 3 times a day.
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: Placebo
    50 subjects taking placebo pills 3 times a day
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01082445
NACPIEDE
No
Valentino Martina, University of Turin, Italy
University of Turin, Italy
Not Provided
Principal Investigator: Valentino Martina, Professor University of Turin
University of Turin, Italy
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP