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Completed

NCT Number: NCT01082445

Effects of N-acetylcysteine on Diabetic Foot Oxygenation

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.

Completed

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Key information

Conditions

Foot Ulcer, Diabetic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Div. Endocrinology, Diabetology and Metabolism - University of Turin

Turin, TO, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcysteine

Drug

600 mg, 1 tablet 3 times a day for 3 months

Other names: Fluimucil (R) 600 mg, tablets

Placebo

Drug

Placebo

Primary outcomes

  1. Tissue oxygenation improvement

    Time frame: Basal (time 0) and after 3 months of treatment/observation

Secondary outcomes

  1. Improvement of the endothelial function

    Time frame: Basal (time 0) and after 3 months of treatment/observation

    nitrites/nitrates - ICAM - VCAM - PAI-1

  2. Oxidation status reduction

    Time frame: Basal (time 0) and after 3 months of treatment/observation

    8-iso PGF-2alpha assessment

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 8, 2010
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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