Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.

NCT05168215 | Unknown

• 1 other identifier: 2020-BSN-EL-128
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Digital Ulcers (DEs), are painful open sores on the fingers and toes and are due to limited perfusion of blood vessels in patients with Scleroderma. In particular, ulcers are caused by narrowing of the arteries, resulting in reduced blood supply to the fingers, causing pain and difficult to heal leaving deep scars. DEs may be present on the rails or fingertips, on the extensor surfaces of the joints, and depending on the underlying calcification. The etiology of ulcers is multifactorial. Raynaud's ischemia, sclerosis, dry skin, calcification and local trauma can all contribute to the onset of Digital Ulcers. Spontaneous fissures or ruptures can also develop into ulcers in patients with scleroderma and severe Raynaud's disease. Whatever the reason for their appearance, DEs negatively affect the quality of life of patients as they complicate even simple daily activities, while they can lead to serious complications such as osteomyelitis or other serious soft tissue infections, up to amputation. Over the last decade, in several randomized clinical trials, DEs have been studied in detail, which are defined or classified differently in each case. The clinical treatment of patients with DE would be facilitated by the availability of specific criteria for the classification of DE. Internationally, the classification of pressure ulcers is usually followed, but this classification is not sufficient for all types of DE observed in Scleroderma. The lack of a clear classification of DEs prompted researchers to evaluate the frequency and morphology of lesions, their characteristics, their physical course, and their healing time in groups of patients with Scleroderma. In a recent study, three categories of classification of digital ulcers based on the patient's clinical picture were proposed by the UK Scleroderma Study Group (UKSSG).

Conditions

Scleroderma; Digital Ulcer; Autoimmune Diseases; Diffuse Cutaneous Systemic Sclerosis; Reynold Syndrome

Outcome Measures

Primary Outcomes (1)

• Digital Ulcers

  The change in the number of finger ulcers and the appearance or not of new ones.

  0-18 months

Secondary Outcomes (4)

• Modified Rodnan Skin Score (ΜRSS)

  18 months

• Raynaud's Condition Score RCS

  0-18 months

• EUSTAR activity index

  0-18 months

• Adverse Events, AE

  0-18 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have been diagnosed with scleroderma (both types:diffuse or limited) and at least one digital ulcer. These patients have been categorised with a total score of ≥ 9 according to 2013 ACR / EULAR Classification Criteria. Regarding current treatment sceme theya are already taking Bosentan (Klimurtan®)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Laikon Hospital of Athens

Athens, Greece

RECRUITING

Related Publications (21)

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Related Links

• Related Info

MeSH Terms

Conditions

Scleroderma, Diffuse; digital ulcers; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 23, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

GR (1)