An observational study in Scleroderma, Digital Ulcer and Autoimmune Diseases, sponsored by Elpen Pharmaceutical Co. Inc.. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Elpen Pharmaceutical Co. Inc. · 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).
In general, targeted future research is needed to improve the reliability of the clinical evaluation of Finger Ulcers for their treatment and to optimize the quality of life of patients.
Systemic Sclerosis Criteria (Scleroderma) In 1980, the American College of Rheumatology (ACR), in conjunction with the European League Against Rheumatism (EULAR), defined the classification criteria for Systemic Sclerosis / Scleroderma. Due to the lack of sensitivity in locating the early stages of Scleroderma and especially the limited cutaneous Systemic Scleroderma, the classification criteria were revised in 2013. It has been found that the thickening of the skin of the fingers that extends near the metacarpophalangeal joints is sufficient to classify the patient with Scleroderma, if this is not obvious, seven additional elements apply, each with a different severity. Specifically, the data are: thickening of the skin of the fingers, finger lesions, teleangiectasia, abnormal capillaries, interstitial pneumonia or Pulmonary Arterial Hypertension, Raynaud's phenomenon and autoantibodies associated with All cases of patients with Scleroderma according to the ACR criteria of 1980 were also classified with Scleroderma and the new criteria of 2013, where several additional cases of patients with Systemic Sclerosis were added.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's planned enrollment of 300 is above the median of 113 across 68 observational studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →Elpen Pharmaceutical Co. Inc. is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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®)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Digital Ulcers
The change in the number of finger ulcers and the appearance or not of new ones.
Time frame: 0-18 months
Modified Rodnan Skin Score (ΜRSS)
The change in the rating on the modified Rodnan leather scale
Time frame: 18 months
Raynaud's Condition Score RCS
The change in the rating on the Raynaud scale
Time frame: 0-18 months
EUSTAR activity index
The change in the score on the EUSTAR activity scale
Time frame: 0-18 months
Adverse Events, AE
Number of Adverse Events during the study period
Time frame: 0-18 months
Started Jan 2022 (actual). Primary completion is estimated for Jun 2024, 29 months after the start.
Of 32 observational studies under Scleroderma, Diffuse, half reached primary completion within 80 months of starting (the median), counting those still running; a quarter within 44. This study's planned 29 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Elpen Pharmaceutical Co. Inc. →