Systemic SclerodermaPhase 3SEDUCENCT01295736
Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY
A Phase 3 study testing Sildenafil in people with Systemic Scleroderma, run by University Hospital, Lille at 24 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 24 sitesFrance
- Study dates
- Nov 2010to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 31Show fewer
- 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 having received a treatment with sildenafil for digital ulcers or pulmonary arterial hypertension within 3 months prior to inclusion.
- Patient having received a treatment with parenteral prostanoids (prostaglandin E, epoprostenol, treprostinil sodium or other prostacyclin analogs) within 3 months prior to inclusion.
- Patient having received a treatment with inhaled or oral prostanoids one month prior to inclusion.
- 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.
- Patient receiving all forms of prostacyclin or nitrates or nitric oxide donors in any form including Nicorandil.
- Patient receiving potent inhibitors of CYP3A4 such as ketoconazole, itraconazole, ritonavir.
- Patient with any condition that prevents compliance with the protocol or adhering to therapy.
- Patient who has donated blood during the previous month or intends to donate blood or blood products during the study or for one month following completion of the study.
- Patient under guardianship (including curators) or deprived of liberty.
- Patient presenting with an anatomic malformation of penis (such as an angulation, sclerosis of erectile tissue or "Lapeyronie's disease").
- Patient presenting with a disease which predisposes to priapism (such as sickle-cell disease, myeloma or leukemia).
- Patient presenting with at least one digital ulcer meeting the exclusion criteria (see below).
- Relative to each DU:
- Digital ulcer due to conditions other than scleroderma.
- Non ischaemic digital ulcer.
- Infected digital ulcer requiring systemic antibiotherapy.
- Digital ulcer requiring urgent surgery.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
University Hospital, Amiens
Amiens, Somme, 80000
Jean Verdier Hospital
Bondy, Île-de-France Region, 93130
CHU de Caen
Caen, Calvados, 14033
CHU Dijon
Dijon, Côte d'Or, 21000
University Hospital, Fort de France
Fort de France, Martinique, 97 261
University Hospital, Grenoble
Grenoble, Isère, 38043
University Hospital, Lille
Lille, Nord, 59037
CHU Dupuytren / dermatology
Limoges, Haute Vienne, 87042
CHU Dupuytren / Médecine Interne
Limoges, Haute Vienne, 87042
Hôpital Edouard Herriot
Lyon, 69437
Nord Hospital
Marseille, Bouches du Rhone, 13915
University Hospital, Nantes
Nantes, Loire-Atlantique, 44000
University Hospital, Nice
Nice, Alpes-Maritimes, 06000
St Louis Hospital
Paris, PARIS, 75010
La Pitié - Salpétriêre Hospital
Paris, Île-de-France Region, 75013
Cochin Hospital / Médecine Interne
Paris, Île-de-France Region, 75014
Cochin Hospital
Paris, Île-de-France Region, 75014
Saint Antoine Hospital
Paris, Île-de-France Region, 75571
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75674
CHU de Reims
Reims, Marne, 51092
CHU de Rennes
Rennes, Ile Et Vilaine, 35203
University Hospital, Rouen
Rouen, Seine-Maritime, 76000
Hautepierre Hospital
Strasbourg, Bas-Rhin, 67098
University Hospital, Tours
Tours, Indre-et-Loire, 37000
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Systemic Scleroderma
- Being tested
- Sildenafil, placebo
- Keywords
- scleroderma, digital, ulcer
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Sildenafil 20 mg TID per os during 90 days
placeboDrug
Placebo pills TID per os during 90 days
| Study group | Role | What they receive |
|---|---|---|
| Actif arm | Active comparator | Sildenafil 20mg TID during 90 days Receives: Drug: Sildenafil |
| Sugar pill | Placebo comparator | Placebo pills TID during 90 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to healing of ischemic digital ulcers (DUs) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days
Measured: 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.
Measured: 90 days
To evaluate the change in the number of ischaemic DUs between baseline and day 90.
Measured: 90 days
To evaluate the proportion of patients with complete healing of all DUs present at baseline at day 90.
Measured: 90 days
To evaluate the proportion of patients with complete healing of all DUs (baseline DUs and new DUs) at day 90.
Measured: 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.
Measured: 90 days
To evaluate the change between baseline and day 90 in hand function and pain.
Measured: 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.
Measured: 90 days
To evaluate the evolution of the severity of Raynaud's phenomenon between baseline and day 90.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric HACHULLA, PU-PH, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295736
- Sponsor's protocol ID
- 2010-021135-13
- Other IDs
- 2010_14
- Acronym
- SEDUCE
- Status last verified
- Jul 2012
- First submitted
- 11 Feb 2011
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25995322
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01295736
- Acronym / sponsor ID
- SEDUCE / 2010-021135-13
- Conditions
- Systemic Scleroderma
- Keywords
- scleroderma, digital, ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actif arm | Active comparator | Drug: SildenafilSildenafil 20mg TID during 90 days |
| Sugar pill | Placebo comparator | Drug: placeboPlacebo pills TID during 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (31 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilSildenafil 20 mg TID per os during 90 days | Drug | Actif arm |
| placeboPlacebo pills TID per os during 90 days | Drug | Sugar pill |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 25995322Hachulla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric HACHULLA, PU-PH principal investigator
University Hospital, Lille
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil in people with Systemic Scleroderma, run by University Hospital, Lille at 24 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01295736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.