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Can a viagra drug heal scleroderma finger sores?

NCT ID NCT01295736

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether sildenafil (the drug in Viagra) can help heal painful finger ulcers in people with scleroderma, a disease that damages blood vessels. 84 participants took either sildenafil or a placebo three times daily for 90 days. The main goal was to see if the ulcers healed faster with sildenafil.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sildenafil (20 mg three times daily)
What this could lead to
If it works, sildenafil could speed up healing of painful finger ulcers in people with scleroderma, improving hand function and quality of life.
What could go wrong
This is a completed Phase 3 trial with only 84 participants. Sildenafil may not heal ulcers faster than placebo, and side effects like headache or flushing are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

84 people

The number who actually took part.

Start date

Nov 2010

Finished

Aug 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma systemic sclerosis ulcer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic scleroderma

Contacts and locations

Locations

  • CHU Dijon

    Dijon, Côte d'Or, 21000, France

  • CHU Dupuytren / Médecine Interne

    Limoges, Haute Vienne, 87042, France

  • CHU Dupuytren / dermatology

    Limoges, Haute Vienne, 87042, France

  • CHU de Caen

    Caen, Calvados, 14033, France

  • CHU de Reims

    Reims, Marne, 51092, France

  • CHU de Rennes

    Rennes, Ile Et Vilaine, 35203, France

  • Cochin Hospital

    Paris, Île-de-France Region, 75014, France

  • Cochin Hospital / Médecine Interne

    Paris, Île-de-France Region, 75014, France

  • Groupe Hospitalier Paris Saint Joseph

    Paris, Île-de-France Region, 75674, France

  • Hautepierre Hospital

    Strasbourg, Bas-Rhin, 67098, 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

  • Nord Hospital

    Marseille, Bouches du Rhone, 13915, France

  • Saint Antoine Hospital

    Paris, Île-de-France Region, 75571, France

  • St Louis Hospital

    Paris, PARIS, 75010, France

  • University Hospital, Amiens

    Amiens, Somme, 80000, France

  • University Hospital, Fort de France

    Fort de France, Martinique, 97 261, France

  • University Hospital, Grenoble

    Grenoble, Isère, 38043, France

  • University Hospital, Lille

    Lille, Nord, 59037, France

  • University Hospital, Nantes

    Nantes, Loire-Atlantique, 44000, France

  • University Hospital, Nice

    Nice, Alpes-Maritimes, 06000, France

  • University Hospital, Rouen

    Rouen, Seine-Maritime, 76000, France

  • University Hospital, Tours

    Tours, Indre-et-Loire, 37000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.