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Effects of N-acetylcysteine on Diabetic Foot Oxygenation

Information source: University of Turin, Italy
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Foot Ulcer, Diabetic

Intervention: N-acetylcysteine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Turin, Italy

Official(s) and/or principal investigator(s):
Valentino Martina, Professor, Principal Investigator, Affiliation: University of Turin

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Tissue oxygenation improvement

Secondary outcome:

Improvement of the endothelial function

Oxidation status reduction

Eligibility

Minimum age: 45 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Div. Endocrinology, Diabetology and Metabolism - University of Turin, Turin, TO 10126, Italy
Additional Information

International Working Group on the Diabetic Foot

Related 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. doi: 10.2337/dc07-2251. 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.

Starting date: August 2009
Last updated: March 7, 2012

Page last updated: August 23, 2015

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