Secondary Raynaud's Phenomenon Clinical Trial
Official title:
Safety and Efficacy Study of Pl-vegf165 to Treat Secondary Raynaud's Phenomenon Caused by Systemic Scleroderma
The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of digital ulcers related to secondary Raynaud's phenomenon associated with systemic scleroderma
This is a randomized, open, comparing clinical trial assessing the therapeutic efficacy of
pl-vegf165 (Neovasculgen) in treating scleroderma-associated Raynaud's syndrome. Each
patient of clinical group will undergo several intramuscular injections with a treatment
dose of pl-vegf165 (Neovasculgen) in hand where digital ulcers locate. In the control group
patients will receive only standard of care without gene therapy drug.
Study participants at the first study visit will complete study questionnaires, their hands
will be assessed clinically for digital ulceration, and their hands will undergo
non-invasive capillaroscopy. After this initial assessment, the patients of clinical group
will undergo intramuscular injections of pl-vegf165 (Neovasculgen) in a hand altered with
digital ulcers.
Patient will report the severity of their Raynaud's symptoms weekly over the six month study
period. At three month post-injection, the patient will complete study questionnaires, their
hands will be assessed clinically for digital ulceration, and their hands will undergo
non-invasive capillaroscopy. At six months post-injection, the patient will again complete
study questionnaires, their hands will be assessed clinically for digital ulceration, and
their hands will undergo non-invasive capillaroscopy.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment