Effects of N-acetylcysteine on Diabetic Foot Oxygenation

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

Condition Intervention Phase
Foot Ulcer, Diabetic
Drug: N-acetylcysteine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients

Resource links provided by NLM:

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Tissue oxygenation improvement [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Enrollment: 100
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-acetylcysteine
50 patients that receive 600 mg of acetylcysteine for 3 times a day.
Drug: N-acetylcysteine
600 mg, 1 tablet 3 times a day for 3 months
Other Name: Fluimucil (R) 600 mg, tablets
Placebo Comparator: Placebo
50 subjects taking placebo pills 3 times a day
Drug: Placebo


Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01082445

Div. Endocrinology, Diabetology and Metabolism - University of Turin
Turin, TO, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Principal Investigator: Valentino Martina, Professor University of Turin
  More Information

Additional Information:
Responsible Party: Valentino Martina, Aggregated Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01082445     History of Changes
Other Study ID Numbers: NACPIEDE 
Study First Received: March 4, 2010
Last Updated: March 7, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Turin, Italy:
stage C
grade 0 (Texas University)

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Vascular Diseases
Anti-Infective Agents
Antiviral Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016