Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY
SEDUCE
Evaluation of the Efficacy of Sildenafil on Time to Healing in Patients With Scleroderma and Ischaemic Digital Ulcers: a Prospective, Longitudinal, Randomized, Comparative, Double-blind, 2-parallel-arm, Placebo-controlled Study
2 other identifiers
interventional
84
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2010
Typical duration for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMay 14, 2026
July 1, 2012
2.8 years
February 11, 2011
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to healing of ischemic digital ulcers (DUs) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days
90 days
Secondary Outcomes (8)
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.
90 days
To evaluate the change in the number of ischaemic DUs between baseline and day 90.
90 days
To evaluate the proportion of patients with complete healing of all DUs present at baseline at day 90.
90 days
To evaluate the proportion of patients with complete healing of all DUs (baseline DUs and new DUs) at day 90.
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.
90 days
- +3 more secondary outcomes
Study Arms (2)
Actif arm
ACTIVE COMPARATORSildenafil 20mg TID during 90 days
Sugar pill
PLACEBO COMPARATORPlacebo pills TID during 90 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 12 months.
- Patient with a history of upper extremity deep vein thrombosis or lymphedema within the previous 3 months.
- Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months.
- Patient with previous intolerance or allergy to PDE5 inhibitors or a history of multiple clinically significant allergies.
- Pregnant or lactating female.
- Patient with uncontrolled tachyarrhythmias or bradyarrhythmias, or placement of pacemaker or implantable defibrillator within 60 days prior to randomization.
- Patient with hemodynamic instability or systolic arterial pressure less than 90 mmHg and/or symptomatic orthostatic hypotension.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University Hospital, Nice
Nice, Alpes-Maritimes, 06000, France
Hautepierre Hospital
Strasbourg, Bas-Rhin, 67098, France
Nord Hospital
Marseille, Bouches du Rhone, 13915, France
CHU de Caen
Caen, Calvados, 14033, France
CHU Dijon
Dijon, Côte d'Or, 21000, France
CHU Dupuytren / dermatology
Limoges, Haute Vienne, 87042, France
CHU Dupuytren / Médecine Interne
Limoges, Haute Vienne, 87042, France
CHU de Rennes
Rennes, Ile Et Vilaine, 35203, France
University Hospital, Tours
Tours, Indre-et-Loire, 37000, France
University Hospital, Grenoble
Grenoble, Isère, 38043, France
University Hospital, Nantes
Nantes, Loire-Atlantique, 44000, France
CHU de Reims
Reims, Marne, 51092, France
University Hospital, Fort de France
Fort de France, Martinique, 97 261, France
University Hospital, Lille
Lille, Nord, 59037, France
St Louis Hospital
Paris, PARIS, 75010, France
University Hospital, Rouen
Rouen, Seine-Maritime, 76000, France
University Hospital, Amiens
Amiens, Somme, 80000, France
Hôpital Edouard Herriot
Lyon, 69437, France
Jean Verdier Hospital
Bondy, Île-de-France Region, 93130, France
La Pitié - Salpétriêre Hospital
Paris, Île-de-France Region, 75013, France
Cochin Hospital / Médecine Interne
Paris, Île-de-France Region, 75014, France
Cochin Hospital
Paris, Île-de-France Region, 75014, France
Saint Antoine Hospital
Paris, Île-de-France Region, 75571, France
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75674, France
Related Publications (1)
Hachulla E, Hatron PY, Carpentier P, Agard C, Chatelus E, Jego P, Mouthon L, Queyrel V, Fauchais AL, Michon-Pasturel U, Jaussaud R, Mathian A, Granel B, Diot E, Farge-Bancel D, Mekinian A, Avouac J, Desmurs-Clavel H, Clerson P; SEDUCE study group. Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study. Ann Rheum Dis. 2016 Jun;75(6):1009-15. doi: 10.1136/annrheumdis-2014-207001. Epub 2015 May 20.
PMID: 25995322RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric HACHULLA, PU-PH
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 14, 2011
Study Start
November 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
May 14, 2026
Record last verified: 2012-07