NCT01082445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

March 4, 2010

Last Update Submit

March 7, 2012

Conditions

Foot Ulcer, Diabetic

Keywords

stage Cgrade 0 (Texas University)

Outcome Measures

Primary Outcomes (1)

  • Tissue oxygenation improvement

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

Secondary Outcomes (2)

  • Improvement of the endothelial function

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

  • Oxidation status reduction

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

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

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

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

50 subjects taking placebo pills 3 times a day

Drug: Placebo

Interventions

N-acetylcysteineDRUG

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

Also known as: Fluimucil (R) 600 mg, tablets
N-acetylcysteine
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Div. Endocrinology, Diabetology and Metabolism - University of Turin

Turin, TO, 10126, Italy

Location

Related Publications (4)

  • 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.

    PMID: 18268065BACKGROUND

  • 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.

    PMID: 19636205BACKGROUND

  • 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.

    PMID: 11227730BACKGROUND

  • 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.

    PMID: 6102928BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetic Foot

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Valentino Martina, Professor

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aggregated Professor

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 8, 2010

Study Start

August 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

IT(1)