Digital ulcers (DUs) are an expression of the microangiopathy in patients with scleroderma (SSc). DUs lead to pain and impaired hand use. DUs remain a severe complication for many patients and effective therapy remains elusive. In the present study, the investigators propose to evaluate the efficacy of Sildenafil in DUs healing in a randomized double blind control study in SSc patients.
This is a multicenter, prospective, longitudinal, randomized, comparative, double-blind, 2-parallel-arm, placebo-controlled study aimed to evaluate the efficacy of sildenafil 20 mg TID study on time to healing of DUs in SSc patients with ischaemic DUs. Approximately 120 patients aged from 18 years and above will be allocated to receive either placebo or sildenafil 20mg TID during 90 days. All potential subjects will present with ischaemic digital ulcers complicating scleroderma. An eligible digital ulcer must be beyond the proximal interphalangeal joint, on finger surface (included periungual ulcers), of ischemic origin according to the physician, and not over subcutaneous calcifications or bone relief.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Sildenafil 20 mg TID per os during 90 days
Placebo pills TID per os during 90 days
University Hospital, Nice
Nice, Alpes-Maritimes, France
time to healing of ischemic digital ulcers (DUs) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days
Time frame: 90 days
To evaluate the time to healing of ischemic DUs (2 mm at entry and > 1 month and <3 months old) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days.
Time frame: 90 days
To evaluate the change in the number of ischaemic DUs between baseline and day 90.
Time frame: 90 days
To evaluate the proportion of patients with complete healing of all DUs present at baseline at day 90.
Time frame: 90 days
To evaluate the proportion of patients with complete healing of all DUs (baseline DUs and new DUs) at day 90.
Time frame: 90 days
To evaluate the proportion of patients who do not develop any new DU after 28 days of treatment with the study drug up to day 90.
Time frame: 90 days
To evaluate the change between baseline and day 90 in hand function and pain.
Time frame: 90 days
To evaluate the proportion of patients with complicated DUs (infection, gangrene, amputation, DU requiring IV prostanoids) over the 90 days period of treatment.
Time frame: 90 days
To evaluate the evolution of the severity of Raynaud's phenomenon between baseline and day 90.
Time frame: 90 days
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