Systemic SclerosisNCT01836263
Prevention and Treatment of Digital Ulcers in Systemic Sclerosis
An observational study of Systemic Sclerosis and Ulcer, run by marco matucci cerinic at 11 sites in 6 countries.
Trial summary
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Sclerosis, Ulcer
- Type of treatment
- Injection or infusion
- How many people
- 420 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Apr 2013to Jun 2017
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population are adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database), the VEDOSS cohort and the jSScWG cohort
Who may be able to join
- Juvenile and adult patients with diagnosis of systemic sclerosis according to the ACR/EULAR SSc criteria or the PRES/ACR/EULAR juvenile SSc criteria for enrollment into the prevention and healing arm
- Patients with fulfilment of the preliminary criteria for very eary diagnosis of systemic sclerosis (VEDOSS criteria) for enrollment into the prevention arm
- Patients with active digital ulcers will be allocated into the healing arm. Patients without previous or history of digital ulcers (but currently without active digital ulcers) will be allocated into the prevention arm.
- Definition of digital ulcers (DU): DU are 1) loss of tissue, 2) DU derived from digital pitting scars and 3) DU derived from calcinosis.
- IN THIS STUDY WE CONSIDER ONLY DU (1) LOSS OF TISSUE. THE OTHER DU (2) and DU (3) ARE REGISTERED IN THE DATA BASE IF THEY ARE PRESENT, BUT ARE EXCLUDED FROM EVALUATION.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 6 countries.
Marco Matucci-Cerinic, Prof. contact
Francesco Del Galdo, Prof. contact
11 sites in 6 countries
Germany3 sites, 3 recruiting
- Recruiting
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, 61231
Ulf Müller-Ladner, Prof.
Ingo H. T, Dr.
- Recruiting
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, 10117
Gabriela Riemekasten, Prof.
- Recruiting
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, 22081
Ivan Foeldvari, Dr.
Italy2 sites, 2 recruiting
- Recruiting
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, 50139
Marco Matucci-Cerinic, Prof.
- Recruiting
Policlinico, Via Pansini
Napoli-Italia, 5-80131
Gabriele Valentini, Prof.
Switzerland2 sites, 2 recruiting
- Recruiting
Felix-Platter Spital, University of Basel
Basel, CH 4012
Ulrich Walker, Prof.
- Recruiting
University of Zurich, Department of Rheumatology
Zurich, 8006
Oliver Distler, Prof.
United Kingdom2 sites, 2 recruiting
- Recruiting
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
Leeds, LS9 7TF
Francesco Del Galdo, Dr.
- Recruiting
Royal Free Hospital, University College London
London, NW3 2QG
Christopher Denton, Prof.
France1 site, 1 recruiting
- Recruiting
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, 75014
Yannick Allanore, Prof.
Hungary1 site, 1 recruiting
- Recruiting
Pecsi Tudomanyegyetem - University of Pecs
Pécs, H-7622
Laszlo Czirjak, Prof.
About this study
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs.
Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy. Consequently, there are at least three types of DU: (i) those localized at the tips of the fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management.
Read more
This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis.
Aim of this observational trial is:
- To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis
- To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria
Thus, the observational trial consist of a prevention arm and a healing arm.
- Conditions
- Systemic Sclerosis, Ulcer
- Medical subject headings
- Scleroderma, Systemic, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prevention arm: CCB & i.v. iloprost | prevention arm: patients receiving a combination of calcium channel blockers (CCB) and concomitant i.v. iloprost (i.v. iloprost at least in the last three months) | |
| Prevention arm: bosentan & sildenafil | prevention arm: patients receiving a combination of the endothelin receptor antagonist bosentan and the Phosphodiesterase-5 inhibitor sildenafil | |
| Healing arm: CCB & i.v. iloprost | healing arm: patients receiving a combination of calcium channel blockers (CCB) and concomitant i.v. iloprost (i.v. iloprost at least in the last three months) | |
| Healing arm: bosentan & sildenafil | healing arm: patients receiving a combination of the endothelin receptor antagonist bosentan and the Phosphodiesterase-5 inhibitor sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention arm: Number of new digital ulcers
Measured: 24 months
Healing arm: Time to healing of manifest digital ulcers
Measured: 24 months
Secondary outcomes (2)
Prevention arm: Time to development of new digital ulcers
Measured: 24 months
Healing arm: Number of healed digital ulcers
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- marco matucci cerinic
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, University of Giessen, University of Zurich, University of Paris 5 - Rene Descartes, University of Campania Luigi Vanvitelli, University of Basel, University College, London, Charite University, Berlin, Germany, University of Pecs, University of Leeds, Schoen Klinik Hamburg Eilbek
- Responsible party
- Sponsor-investigator, marco matucci cerinic, University of Florence
- Investigators
- Marco Matucci-Cerinic, Prof., Principal investigator, University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of BiomedicineFrancesco Del Galdo, Dr., Principal investigator, The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University HospitalUlf Müller-Ladner, Prof., Study chair, Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836263
- Sponsor's protocol ID
- HEALTH-F5-2012-305495-OT1
- Status last verified
- Apr 2013
- First submitted
- 16 Apr 2013
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Blagojevic J, Bellando-Randone S, Abignano G, Avouac J, Cometi L, Czirjak L, Denton CP, Distler O, Frerix M, Guiducci S, Huscher D, Jaeger VK, Lorand V, Maurer B, Nihtyanova S, Riemekasten G, Siegert E, Tarner IH, Vettori S, Walker UA, Allanore Y, Muller-Ladner U, Del Galdo F, Matucci-Cerinic M; EUSTAR co-workers. Classification, categorization and essential items for digital ulcer evaluation in systemic sclerosis: a DeSScipher/European Scleroderma Trials and Research group (EUSTAR) survey. Arthritis Res Ther. 2019 Jan 24;21(1):35. doi: 10.1186/s13075-019-1822-1.
PubMed 30678703
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Digital Ulcers in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01836263
- Acronym / sponsor ID
- HEALTH-F5-2012-305495-OT1
- Conditions
- Systemic Sclerosis, Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- marco matucci cerinicUniversity, hospital or other
- Collaborators
- European Union, University of Giessen, University of Zurich, University of Paris 5 - Rene Descartes, University of Campania Luigi Vanvitelli, University of Basel, University College, London, Charite University, Berlin, Germany, University of Pecs, University of Leeds, Schoen Klinik Hamburg Eilbek
- Study start
- Apr 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Apr 2013 (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.
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs.
Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy. Consequently, there are at least three types of DU: (i) those localized at the tips of the fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management.
This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis.
Aim of this observational trial is:
- To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis
- To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria
Thus, the observational trial consist of a prevention arm and a healing arm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prevention arm: CCB & i.v. iloprost | – | –prevention arm: patients receiving a combination of calcium channel blockers (CCB) and concomitant i.v. iloprost (i.v. iloprost at least in the last three months) |
| Prevention arm: bosentan & sildenafil | – | –prevention arm: patients receiving a combination of the endothelin receptor antagonist bosentan and the Phosphodiesterase-5 inhibitor sildenafil |
| Healing arm: CCB & i.v. iloprost | – | –healing arm: patients receiving a combination of calcium channel blockers (CCB) and concomitant i.v. iloprost (i.v. iloprost at least in the last three months) |
| Healing arm: bosentan & sildenafil | – | –healing arm: patients receiving a combination of the endothelin receptor antagonist bosentan and the Phosphodiesterase-5 inhibitor sildenafil |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database), the VEDOSS cohort and the jSScWG cohort
Key inclusion criteria (5 listed)
- Juvenile and adult patients with diagnosis of systemic sclerosis according to the ACR/EULAR SSc criteria or the PRES/ACR/EULAR juvenile SSc criteria for enrollment into the prevention and healing arm
- Patients with fulfilment of the preliminary criteria for very eary diagnosis of systemic sclerosis (VEDOSS criteria) for enrollment into the prevention arm
- Patients with active digital ulcers will be allocated into the healing arm. Patients without previous or history of digital ulcers (but currently without active digital ulcers) will be allocated into the prevention arm.
- Definition of digital ulcers (DU): DU are 1) loss of tissue, 2) DU derived from digital pitting scars and 3) DU derived from calcinosis.
- IN THIS STUDY WE CONSIDER ONLY DU (1) LOSS OF TISSUE. THE OTHER DU (2) and DU (3) ARE REGISTERED IN THE DATA BASE IF THEY ARE PRESENT, BUT ARE EXCLUDED FROM EVALUATION.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevention arm: Number of new digital ulcers
Time frame: 24 months
Healing arm: Time to healing of manifest digital ulcers
Time frame: 24 months
2 secondary outcomes
Prevention arm: Time to development of new digital ulcers
Time frame: 24 months
Healing arm: Number of healed digital ulcers
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Derived from this study: PubMed 30678703Blagojevic J, Bellando-Randone S, Abignano G, Avouac J, Cometi L, Czirjak L, Denton CP, Distler O, Frerix M, Guiducci S, Huscher D, Jaeger VK, Lorand V, Maurer B, Nihtyanova S, Riemekasten G, Siegert E, Tarner IH, Vettori S, Walker UA, Allanore Y, Muller-Ladner U, Del Galdo F, Matucci-Cerinic M; EUSTAR co-workers. Classification, categorization and essential items for digital ulcer evaluation in systemic sclerosis: a DeSScipher/European Scleroderma Trials and Research group (EUSTAR) survey. Arthritis Res Ther. 2019 Jan 24;21(1):35. doi: 10.1186/s13075-019-1822-1.
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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.
Marco Matucci-Cerinic, Prof. contact
Francesco Del Galdo, Prof. contact
Marco Matucci-Cerinic, Prof. principal investigator
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Francesco Del Galdo, Dr. principal investigator
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
Ulf Müller-Ladner, Prof. study chair
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Ulcer, run by marco matucci cerinic at 11 sites in 6 countries.
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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 25 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Italy, Switzerland, United Kingdom, France and 1 more country. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Matucci-Cerinic, Prof. (marco.matuccicerinic@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention arm: Number of new digital ulcers (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT01836263, which also lists 1 linked publication.
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 25 Apr 2013.