Systemic Sclerosis Clinical Trial
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:
1. 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
2. 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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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|
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| Terminated |
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|
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| Completed |
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|
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Phase 3 | |
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|
||
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||
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