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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine | Experimental | 50 patients that receive 600 mg of acetylcysteine for 3 times a day. |
|
| Placebo | Placebo Comparator | 50 subjects taking placebo pills 3 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | 600 mg, 1 tablet 3 times a day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue oxygenation improvement | Basal (time 0) and after 3 months of treatment/observation |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of the endothelial function | nitrites/nitrates - ICAM - VCAM - PAI-1 | Basal (time 0) and after 3 months of treatment/observation |
| Oxidation status reduction | 8-iso PGF-2alpha assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valentino Martina, Professor | University of Turin, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Div. Endocrinology, Diabetology and Metabolism - University of Turin | Turin | TO | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18268065 | Background | 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. | |
| 19636205 |
| Label | URL |
|---|---|
| International Working Group on the Diabetic Foot | View source |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo |
|
| Basal (time 0) and after 3 months of treatment/observation |
| Background |
| 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. |
| 11227730 | Background | 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. |
| 6102928 | Background | 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. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |