Bosentan therapy for patients with scleroderma and digital ulcers
An Observational Clinical Study to evalUate the Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.
This study is testing if Bosentan therapy can help adults with scleroderma and painful digital ulcers heal their sores and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Elpen Pharmaceutical Co. Inc. Industry-sponsored |
| Locations | 1 site (Athens) |
| Trial ID | NCT05168215 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of Bosentan therapy in adult patients diagnosed with scleroderma who have at least one digital ulcer. Digital ulcers are painful sores that can significantly impair quality of life due to reduced blood flow and other complications associated with scleroderma. The study aims to assess the healing of these ulcers and the overall impact of Bosentan on patient outcomes. Participants must already be taking Bosentan and meet specific classification criteria for scleroderma.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with scleroderma who have at least one digital ulcer and are currently on Bosentan therapy.
Not a fit: Patients with digital ulcers from causes other than scleroderma or those with severe pulmonary arterial hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve healing rates of digital ulcers and enhance the quality of life for patients with scleroderma.
How similar studies have performed: While there is limited data on the specific use of Bosentan for digital ulcers in scleroderma, similar studies on related therapies have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients * Patients diagnosed with scleroderma (diffuse or limited) * Patients with at least one digital ulcer, whether or not it is due to scleroderma * Patients with 2013 ACR / EULAR Classification Criteria with a total score of ≥ 9 * Patients already taking Bosentan (Klimurtan®) * Patients who will sign the consent form for their participation in the study Exclusion Criteria: * Patients with digital ulcers of other etiology, other than scleroderma * Patients with severe pulmonary arterial hypertension (severe PAH- Category 3-4 according to WHO) * Patients who do not meet the criteria for taking the study drug, according to the Summary of Product Characteristics
Where this trial is running
Athens
- Laikon Hospital of Athens — Athens, Greece (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.