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
  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
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
Placebo

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
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:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
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
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 26, 2014