Effects of N-acetylcysteine on Diabetic Foot Oxygenation - Full Text View

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:

MedlinePlus related topics: Diabetic Foot Foot Health

Drug Information available for: Acetylcysteine

U.S. FDA Resources

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

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:

International Working Group on the Diabetic Foot This link exits the ClinicalTrials.gov site

Publications:

Martina V, Masha A, Gigliardi VR, Brocato L, Manzato E, Berchio A, Massarenti P, Settanni F, Della Casa L, Bergamini S, Iannone A. Long-term N-acetylcysteine and L-arginine administration reduces endothelial activation and systolic blood pressure in hypertensive patients with type 2 diabetes. Diabetes Care. 2008 May;31(5):940-4. Epub 2008 Feb 11.

Masha A, Brocato L, Dinatale S, Mascia C, Biasi F, Martina V. N-acetylcysteine is able to reduce the oxidation status and the endothelial activation after a high-glucose content meal in patients with Type 2 diabetes mellitus. J Endocrinol Invest. 2009 Apr;32(4):352-6.

Martina V, Bruno GA, Zumpano E, Origlia C, Quaranta L, Pescarmona GP. Administration of glutathione in patients with type 2 diabetes mellitus increases the platelet constitutive nitric oxide synthase activity and reduces PAI-1. J Endocrinol Invest. 2001 Jan;24(1):37-41.

Ignarro LJ, Edwards JC, Gruetter DY, Barry BK, Gruetter CA. Possible involvement of S-nitrosothiols in the activation of guanylate cyclase by nitroso compounds. FEBS Lett. 1980 Feb 11;110(2):275-8. No abstract available.

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 June 17, 2013