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Can a blood flow drug ease painful finger ulcers in scleroderma?

NCT ID NCT01395732

Disease control Sponsor: Actelion 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug bosentan in 18 adults with systemic sclerosis who had reduced blood flow in their hands and a history of digital ulcers. The goal was to see if bosentan could improve hand blood flow measured by laser imaging and how blood flow relates to ulcer severity. The trial is already completed.

What this could mean

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

Active substance
Bosentan (a drug taken as tablets to improve blood flow)
What this could lead to
If successful, this could show that bosentan improves hand blood flow and helps manage digital ulcers in systemic sclerosis patients.
What could go wrong
This is a small, completed Phase 4 study with only 18 participants, so results may not apply broadly. The drug may not significantly improve blood flow or ulcer outcomes.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

18 people

The number who actually took part.

Started

Mar 2011

Finished

Dec 2012

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Male and female subjects \> 18 years diagnosed with SSc; * Reduction of blood flow measured by laser Doppler imaging, of at least 50%, distally to the proximal interphalangeal joint, compared to the healthy volunteers; * Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception; * A history of 1 or more DUs within 2 years prior to inclusion; * No use of bosentan in the past; * Subjects willing and able to sign informed consent. Exclusion Criteria: * Parenteral prostanoid treatment for DU \< 3 months ago; * Chronic treatment with PDE-5 inhibitor or ERA; * History of bosentan use * Irreversible significant limitation of the hand function, e.g. amputation of more than one finger; * Other types of system- or connective tissue diseases; * Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy; * Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is \< 12 months; * Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN); * Moderate to severe liver function disorder; * Pregnancy or breastfeeding; * Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors; * Hypersensitivity for bosentan or one of its components; * Subjects not able to follow the protocol.

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Conditions

The condition(s) this trial relates to.

digital ulcers systemic sclerosis

As listed by the trial registrant

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

Digital ulcers Systemic sclerosis

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, 3015CE, Netherlands

  • Isala Klinieken

    Zwolle, 8011JW, Netherlands

  • LUMC

    Leiden, 2333ZA, Netherlands

  • MCL

    Leeuwarden, 8934AD, Netherlands

  • MUMC

    Maastricht, 6229HX, Netherlands

  • Maasstad Ziekenhuis

    Rotterdam, 3078HT, Netherlands

  • Sint Franciscus Gasthuis

    Rotterdam, 3045PM, Netherlands

  • UMC Groningen

    Groningen, 9700RB, Netherlands

  • UMC St Radboud

    Nijmegen, 6525GA, Netherlands

  • VUmc

    Amsterdam, 10811HV, Netherlands

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