Autoimmune Diseases Clinical Trial
— CUREOfficial title:
An Observational Clinical Study to evalUate the Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.
Verified date | October 2023 |
Source | Elpen Pharmaceutical Co. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Laikon Hospital of Athens | Athens |
Lead Sponsor | Collaborator |
---|---|
Elpen Pharmaceutical Co. Inc. |
Greece,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Digital Ulcers | The change in the number of finger ulcers and the appearance or not of new ones. | 0-18 months | |
Secondary | Modified Rodnan Skin Score (?RSS) | The change in the rating on the modified Rodnan leather scale | 18 months | |
Secondary | Raynaud's Condition Score RCS | The change in the rating on the Raynaud scale | 0-18 months | |
Secondary | EUSTAR activity index | The change in the score on the EUSTAR activity scale | 0-18 months | |
Secondary | Adverse Events, AE | Number of Adverse Events during the study period | 0-18 months |
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