Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01082445
NCT01082445
Completed
Phase 3

Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients

University of Turin, Italy1 site in 1 country100 target enrollmentAugust 2009
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsFoot Ulcer, Diabetic
InterventionsN-acetylcysteinePlacebo
DrugsN-acetylcysteinePlacebo

Overview

Phase
Phase 3
Intervention
N-acetylcysteine
Conditions
Foot Ulcer, Diabetic
Sponsor
University of Turin, Italy
Enrollment
100
Locations
1
Primary Endpoint
Tissue oxygenation improvement
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
November 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Turin, Italy
Responsible Party
Principal Investigator
Principal Investigator

Valentino Martina

Aggregated Professor

University of Turin, Italy

Eligibility Criteria

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.

Arms & Interventions

N-acetylcysteine

50 patients that receive 600 mg of acetylcysteine for 3 times a day.

Intervention: N-acetylcysteine

Placebo

50 subjects taking placebo pills 3 times a day

Intervention: Placebo

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(Basal (time 0) and after 3 months of treatment/observation)
  • Oxidation status reduction(Basal (time 0) and after 3 months of treatment/observation)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 2
N-acetylcysteine for Tobacco Use DisorderNicotine DependenceSmoking
NCT02737358Medical University of South Carolina114
Completed
Phase 2
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe DiseaseCOVIDSars-CoV2SARS-Associated Coronavirus as Cause of Disease Classified ElsewhereOxidative Stress
NCT04419025Cambridge Health Alliance165
Not yet recruiting
Phase 3
Investigation of the effect of N-acetylcysteine in rheumatoid arthritisRheumatoid arthritis.Rheumatoid arthritis with rheumatoid factor
IRCT20101014004934N2Kashan University of Medical Sciences74
Completed
Phase 3
Effects of N-acetylcysteine administration in treatment of women with gestational diabetes mellitusGestational diabetes mellitus.Unspecified diabetes mellitus in pregnancy, childbirth and the puerperiumO24.9
IRCT20170513033941N71Kashan University of Medical Sciences76
Completed
Phase 4
Effects of N-acetylcysteine on Low T3 SyndromeAcute Myocardial InfarctionEuthyroid Sick SyndromeIschemic Heart Disease
NCT01501110Federal University of Rio Grande do Sul83