Foot Ulcer, DiabeticPhase 3NCT01082445
Effects of N-acetylcysteine on Diabetic Foot Oxygenation
A Phase 3 study testing N-acetylcysteine in people with Foot Ulcer, Diabetic, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2009to Nov 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Div. Endocrinology, Diabetology and Metabolism - University of Turin
Turin, TO, 10126
About this study
Official title: Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients
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.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- N-acetylcysteine, Placebo
- Keywords
- stage C, grade 0 (Texas University)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Also called Fluimucil (R) 600 mg, tablets
600 mg, 1 tablet 3 times a day for 3 months
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | 50 patients that receive 600 mg of acetylcysteine for 3 times a day. Receives: Drug: N-acetylcysteine |
| Placebo | Placebo comparator | 50 subjects taking placebo pills 3 times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue oxygenation improvement
Measured: Basal (time 0) and after 3 months of treatment/observation
Secondary outcomes (2)
Improvement of the endothelial function
nitrites/nitrates - ICAM - VCAM - PAI-1
Measured: Basal (time 0) and after 3 months of treatment/observation
Oxidation status reduction
8-iso PGF-2alpha assessment
Measured: Basal (time 0) and after 3 months of treatment/observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentino Martina, University of Turin, Italy
- Investigators
- Valentino Martina, Professor, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082445
- Sponsor's protocol ID
- NACPIEDE
- Status last verified
- Mar 2012
- First submitted
- 4 Mar 2010
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18268065Masha 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.
PubMed 19636205Martina 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.
PubMed 11227730Ignarro 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.
PubMed 6102928
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01082445
- Acronym / sponsor ID
- NACPIEDE
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- stage C, grade 0 (Texas University)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Drug: N-acetylcysteine50 patients that receive 600 mg of acetylcysteine for 3 times a day. |
| Placebo | Placebo comparator | Drug: Placebo50 subjects taking placebo pills 3 times a day |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineAlso: Fluimucil (R) 600 mg, tablets600 mg, 1 tablet 3 times a day for 3 months | Drug | N-acetylcysteine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Tissue oxygenation improvement
Time frame: Basal (time 0) and after 3 months of treatment/observation
2 secondary outcomes
Improvement of the endothelial function
Time frame: Basal (time 0) and after 3 months of treatment/observation
Oxidation status reduction
Time frame: Basal (time 0) and after 3 months of treatment/observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Background: PubMed 18268065Martina 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.
- Background: PubMed 19636205Masha 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.
- Background: PubMed 11227730Martina 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.
- Background: PubMed 6102928Ignarro 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.
- International Working Group on the Diabetic FootLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentino Martina, Professor principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-acetylcysteine in people with Foot Ulcer, Diabetic, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue oxygenation improvement (time frame: Basal (time 0) and after 3 months of treatment/observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01082445, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.