Digital Ulcers Outcome (DUO) Registry
The DUO Registry is intended to collect information on digital ulcers (DU) associated with systemic sclerosis (SSc), and their management. The registry will include all consenting patients with DU associated with SSc (DU/SSc), irrespective of their treatment regimen.
The registry meets a post approval commitment to the European Medicines Agency (EMEA), and has two main objectives:
- for Tracleer patients, to record the use of Tracleer in DU/SSc, to document the practices regarding liver function tests (LFTs), pregnancy testing, and the use of adequate contraception in patients with DU/SSc, and to collect safety information
- for all patients, to describe the history, course and outcome of DU/SSc
The registry is an international, multicenter, prospective, observational, non-interventional program for patients with DU/SSc. Participating patients undergo assessments and receive medical or surgical therapies according to their physician's judgment. Patients do not receive any experimental intervention or treatment as a result of their participation in the registry.
An independent scientific committee of medical experts has advised Actelion in the design of this registry, and is included in the review and interpretation of the resulting data.
Data are collected electronically via a secure internet-based system, fully protecting patient privacy. The data collected for all DU patients include patient demographics, past history and present status of SSc and DU, DU complications (e.g., soft tissue infection, gangrene, osteomyelitis), medications (e.g., analgesics, dressings, systemic antibiotics, parenteral prostacyclins), and interventions (e.g., sympathectomy, digital amputation, arthrodesis).
The DUO Registry started in April 2008. Its results are reported to the EMEA in accordance with regulatory requirements, and serve as a basis for scientific publication.