To investigate the ability of divalproex sodium, a histone deacetylase inhibitor, to improve the digital manifestations of scleroderma including digital edema, calcinosis cutis, digital ulcers, and joint contractures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Yale University
New Haven, Connecticut, United States
Number of new digital ulcers
Time frame: 12 months
Change in modified Rodnan skin score
Time frame: 12 months
Change in digital goniometry measurements
Goniometry measures range of motion of joints and, in this study, will include measurements of the metacarpophalangeal, proximal interphalangeal, distal interphalangeal and wrist joints.
Time frame: 12 months
Change in hydraulic pinch and hand-grip strength measurements
Time frame: 12 months
Change in digital circumference
Time frame: 12 months
Change in maximum oral aperture
Time frame: 12 months
Change in estimated affected total body surface area
Time frame: 12 months
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: 12 months
Number of new lesions of calcinosis cutis
Time frame: 12 months
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