Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY (NCT01295736) | Clinical Trial Compass
CompletedPhase 3
Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY
France84 participantsStarted 2010-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with systemic sclerosis (ScS) according to the classification criteria of the American College of Rheumatology or of "LeRoy" and "Medsger".
* ScS patient with at least one ongoing ischaemic hand digital ulcer at baseline (see below the eligibility conditions of a digital ulcer).
* Patient must have provided written informed consent prior to enrolment. Patient agrees to come to the follow up visits inside the protocol specified range.
* Relative to each DU: DU must be beyond the proximal interphalangeal joint, on finger surface, of ischemic origin according to the physician, and not over subcutaneous calcifications or bone relief.
Exclusion Criteria:
* PAH requiring PDE5 inhibitors or prostacyclin history of stroke, myocardial infarction or life threatening arrhythmia within the last 6 months
* severe cardiac failure (NYHA IV) or unstable angina within the last 6 months.
* hereditary degenerative retinal disorders non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy
* uncontrolled diabetes mellitus
* Patient with known severe lung obstructive disease (FEV1\<70% on last available pulmonary function tests).
* severe hepatic impairment
* Patient with known impairment of renal function (serum creatinine \> 2.5 ULN).
* Patient with severe malabsorption or any severe organ failure (e.g., lung, kidney) or any life-threatening condition.
* Patient who has had surgical sympathectomy performed in the previous 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
time to healing of ischemic digital ulcers (DUs) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days