Effects of N-acetylcysteine on Diabetic Foot Oxygenation

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082445
• Other study ID #: NACPIEDE
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2010
• Last updated: March 7, 2012
• Start date: August 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2012
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic

Intervention

Drug:
• N-acetylcysteine
600 mg, 1 tablet 3 times a day for 3 months
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	Div. Endocrinology, Diabetology and Metabolism - University of Turin	Turin	TO

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue oxygenation improvement		Basal (time 0) and after 3 months of treatment/observation	No
Secondary	Improvement of the endothelial function	nitrites/nitrates - ICAM - VCAM - PAI-1	Basal (time 0) and after 3 months of treatment/observation	No
Secondary	Oxidation status reduction	8-iso PGF-2alpha assessment	Basal (time 0) and after 3 months of treatment/observation	No

External Links

•   International Working Group on the Diabetic Foot