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Effects of N-acetylcysteine on Diabetic Foot Oxygenation

Primary Purpose

Foot Ulcer, Diabetic

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

N-acetylcysteine

Placebo

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic focused on measuring stage C, grade 0 (Texas University)

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Div. Endocrinology, Diabetology and Metabolism - University of Turin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetylcysteine

Placebo

Arm Description

50 patients that receive 600 mg of acetylcysteine for 3 times a day.

50 subjects taking placebo pills 3 times a day

Outcomes

Primary Outcome Measures

Tissue oxygenation improvement

Secondary Outcome Measures

Improvement of the endothelial function

nitrites/nitrates - ICAM - VCAM - PAI-1

Oxidation status reduction

8-iso PGF-2alpha assessment

Full Information

NCT ID

NCT01082445

First Posted

March 4, 2010

Last Updated

March 7, 2012

Sponsor

University of Turin, Italy

1. Study Identification

Unique Protocol Identification Number

NCT01082445

Brief Title

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

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Turin, Italy

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Ulcer, Diabetic

Keywords

stage C, grade 0 (Texas University)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

N-acetylcysteine

Arm Type

Experimental

Arm Description

50 patients that receive 600 mg of acetylcysteine for 3 times a day.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

50 subjects taking placebo pills 3 times a day

Intervention Type

Drug

Intervention Name(s)

N-acetylcysteine

Other Intervention Name(s)

Fluimucil (R) 600 mg, tablets

Intervention Description

600 mg, 1 tablet 3 times a day for 3 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Tissue oxygenation improvement

Time Frame

Basal (time 0) and after 3 months of treatment/observation

Secondary Outcome Measure Information:

Title

Improvement of the endothelial function

Description

nitrites/nitrates - ICAM - VCAM - PAI-1

Time Frame

Basal (time 0) and after 3 months of treatment/observation

Title

Oxidation status reduction

Description

8-iso PGF-2alpha assessment

Time Frame

Basal (time 0) and after 3 months of treatment/observation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valentino Martina, Professor

Organizational Affiliation

University of Turin, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Div. Endocrinology, Diabetology and Metabolism - University of Turin

City

Turin

State/Province

ZIP/Postal Code

10126

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

18268065

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.

Results Reference

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PubMed Identifier

19636205

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.

Results Reference

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PubMed Identifier

11227730

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.

Results Reference

background

PubMed Identifier

6102928

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.

Results Reference

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Links:

URL

http://www.iwgdf.org/

Description

International Working Group on the Diabetic Foot

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Effects of N-acetylcysteine on Diabetic Foot Oxygenation

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