Clinical trial NCT01082445: Effects of N-acetylcysteine on Diabetic Foot Oxygenation
Official title: Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Foot Ulcer, Diabetic
Keywords: stage C
grade 0 (Texas University)
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2010-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Tissue oxygenation improvement
timeFrame: Basal (time 0) and after 3 months of treatment/observation
Secondary outcomes:
measure: Improvement of the endothelial function
timeFrame: Basal (time 0) and after 3 months of treatment/observation
measure: Oxidation status reduction
timeFrame: Basal (time 0) and after 3 months of treatment/observation
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Div. Endocrinology, Diabetology and Metabolism - University of Turin
state: TO
Study officials:
affiliation: University of Turin, Italy
name: Valentino Martina, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1007/BF03345726.
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. doi: 10.1007/BF03343806.
citation: 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. doi: 10.1016/0014-5793(80)80091-3. No abstract available.