Clinical trial NCT01377090: Digital Ulceration
Official title: A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Digital Ulcers
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2011-06-21
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Systemic Sclerosis with or without a history of digital ulcers (DU)

Brief summary: The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.


Eligibility criteria: Inclusion Criteria:

For all patients:

* Signed informed consent prior to enrollment
* Male or female, ≥ 18 years of age
* Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria

For patients with no history of digital ulcers (DU) and no DU at enrollment only:

- Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature

Exclusion Criteria:

* SSc sine scleroderma (without any skin involvement)
* Patients who underwent stem cell transplantation
* Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
* Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)

Primary outcomes:
measure: Occurence of first new digital ulcer (DU)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Vienna
country: Austria
facility: Universitätsklinik für Innere Medizin Wien
city: Vienna
country: Austria
facility: Sozialmedizinisches Zentrum Süd-Kaiser-Franz-Josef-Spital
city: Vienna
country: Austria
facility: Hanusch Krankenhaus der Gebietskrankenkasse
city: Brussels
country: Belgium
facility: Université Libre de Bruxelles Hopital Erasme
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Prague
country: Czech Republic
facility: Revmatologický ústav
city: Amiens Cedex 1
country: France
facility: Centre Hospitalier Universitaire Amiens
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Lille
country: France
facility: CHRU de Lille, hopital Claude Huriez, Service des maladies du sang
city: Limoges cedex
country: France
facility: CHU Dupuytren
city: Nantes cedex 1
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Groupe Hospitalier Cochin Saint Vincent de Paul
city: Paris
country: France
facility: Hôpital Tenon
city: Bad Abbach
country: Germany
facility: Asklepios Klinikum Bad Abbach
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Bochum-Gerthe
country: Germany
facility: Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Köln
country: Germany
facility: Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Athens
country: Greece
facility: Laiko Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Brescia
country: Italy
facility: Universita degli Studi di Brescia
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro
city: Genova
country: Italy
facility: Azienda Ospedale San Martino
city: Pisa
country: Italy
facility: Ospedale Santa Ciara
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Roma
country: Italy
facility: Complesso Integrato Columbus
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Lillehammer
country: Norway
facility: Revmatismesykehuset
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Madrid
country: Spain
facility: Hospital de Mostoles
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudoise
city: Sankt Gallen
country: Switzerland
facility: Kantonspital Sankt Gallen
city: Zurich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi
city: Bath
country: United Kingdom
facility: Bath Institute for Rheumatic Diseases
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Salford
country: United Kingdom
facility: Hope Hospital
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
Study officials:
References: