Effects of N-acetylcysteine on Diabetic Foot Oxygenation
NCT ID: NCT01082445
Last Updated: 2012-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2009-08-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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N-acetylcysteine
50 patients that receive 600 mg of acetylcysteine for 3 times a day.
N-acetylcysteine
600 mg, 1 tablet 3 times a day for 3 months
Placebo
50 subjects taking placebo pills 3 times a day
Placebo
Placebo
Interventions
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N-acetylcysteine
600 mg, 1 tablet 3 times a day for 3 months
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 1 or 2 diabetes mellitus with foot ulcer (grade 0 stage C according to Texas University Classification).
* Written informed consent.
Exclusion Criteria
* Hypersensibility to acetylcysteine.
* Neoplasms, severe systemic, hepatic, pulmonary, cardiovascular or renal diseases.
* Psychiatric diseases or drug abuse problems.
45 Years
70 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Valentino Martina
Aggregated Professor
Principal Investigators
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Valentino Martina, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Locations
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Div. Endocrinology, Diabetology and Metabolism - University of Turin
Turin, TO, Italy
Countries
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References
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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. doi: 10.1007/BF03345726.
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.
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.
Related Links
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International Working Group on the Diabetic Foot
Other Identifiers
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NACPIEDE
Identifier Type: -
Identifier Source: org_study_id
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