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Effects of N-acetylcysteine on Diabetic Foot Oxygenation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082445
First Posted: March 8, 2010
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valentino Martina, University of Turin, Italy
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 Valentino Martina, University of Turin, Italy:

Primary Outcome Measures:
  • Tissue oxygenation improvement [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ]

Secondary Outcome Measures:
  • Improvement of the endothelial function [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ]
    nitrites/nitrates - ICAM - VCAM - PAI-1

  • Oxidation status reduction [ Time Frame: Basal (time 0) and after 3 months of treatment/observation ]
    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
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082445


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

Additional Information:
Publications:
Responsible Party: Valentino Martina, Aggregated Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01082445     History of Changes
Other Study ID Numbers: NACPIEDE
First Submitted: March 4, 2010
First Posted: March 8, 2010
Last Update Posted: March 8, 2012
Last Verified: March 2012

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

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