Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.
NCT03558854 — Systemic Sclerosis
Status: Completed
http://inclinicaltrials.com/systemic-sclerosis/NCT03558854/
Randomized Controlled Trial of the Scleroderma Patient-centered Intervention Network Hand Exercise Program
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma (systemic sclerosis or SSc) from Canada, the USA, and Europe. The objectives of SPIN are (1) to assemble a large cohort of SSc patients to complete outcome assessments regularly in order to learn more about important problems faced by people living with SSc and (2) to develop and test a series of internet-based interventions to help patients manage aspects of their disease, including hand limitations. In SSc, approximately 90% of patients experience significant hand function limitations, which impact overall disability more than any other aspect of the disease. The SPIN hand exercise program was designed by SPIN experts in rehabilitation, behavioural therapies, and e-health interventions, as well as patient representatives in SPIN. The program core consists of 4 modules that address specific aspects of hand function, and integrates tools to support key components of successful self-management programs, including goal-setting and feedback, social modeling, and mastery experiences. The SPIN-HAND trial is a pragmatic randomized control trial (RCT) embedded in the SPIN Cohort that will evaluate the effect of SPIN's online hand exercise program, in addition to usual care, on hand function and health related quality of life (HRQL) in SSc patients with at least mild hand function limitations. SPIN will randomize 586 SPIN Cohort participants with at least mild hand function limitations and an indicated interest in using an online hand exercise program to be offered the hand exercise program or usual care only.
NCT03419208 — Systemic Sclerosis
Status: Completed
http://inclinicaltrials.com/systemic-sclerosis/NCT03419208/
A Phase IV, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in Patients With Fibrotic and Atrophic Cutaneous Lesions in Scleroderma Diseases
This is a phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in patients with fibrotic and atrophic cutaneous lesions in scleroderma diseases during the inactive stage of the disease (experiencing dystrophic outcomes of the disease with no inflammatory component at the time of enrolment). The patients enrolled will be evaluated at study site at screening (V1), then after 3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular administration) (V2). After completion of the study treatment period, the patients will be followed for an additional period of 3 months without study medication, after which the patient will visit the site for the last visit (V3). 1 investigational site. 45 patients enrolled (included drop-outs).3 months of treatment with PLACENTEX ® Polydeoxyribonucleotide (one vial per day for intra-muscular administration).
NCT03388255 — Scleroderma Disease
Status: Terminated
http://inclinicaltrials.com/scleroderma-disease/NCT03388255/
Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .
NCT03294616 — Gastroparesis
Status: Completed
http://inclinicaltrials.com/gastroparesis/NCT03294616/
Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.
Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.
NCT03271333 — Systemic Sclerosis
Status: Recruiting
http://inclinicaltrials.com/systemic-sclerosis/NCT03271333/
Use of FLIP Topography to Evaluate Esophageal Symptoms in Patients With Scleroderma
FLIP topography has been FDA cleared to evaluate a variety of esophageal conditions, but has never been evaluated in patients with scleroderma. The investigators hope to evaluate this technology in patients who have scleroderma and various esophageal symptoms, and compare to non-scleroderma patients.
NCT03270722 — Dysphagia
Status: Withdrawn
http://inclinicaltrials.com/dysphagia/NCT03270722/
MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients by Using Elastic Registration Method: Feasibility Study
Assessment of pulmonary fibrosis is currently based on high-resolution CT (HRCT) and pulmonary function tests (PFT) such as forced vital capacity, (FVC) and carbon monoxide diffusion (DLCO). These techniques allow a semi-quantitative analysis of the pulmonary disease but are imperfect. The mains weaknesses are the lack of reproducibility, the limited sensitivity and for CT the resulting radiation dose. Recent advances in MRI sequences allow exploring the lung parenchyma with millimeter slice thickness. Development of computer-assisted post-processing such as elastic registration opens new perspectives in the functional study of the lung parenchyma, especially the analysis of its deformation during the respiratory cycle and therefore of its elasticity. Pulmonary involvement in scleroderma is present in 70 to 100% of patients and is the leading cause of death. Initial assessment of pulmonary involvement and follow-up are important for therapeutic decisions and patient prognosis. Quantitative analysis should be developed to reliably evaluate pulmonary fibrosis and increase the reproducibility. The purpose of our study is to evaluate the feasibility of quantifying pulmonary fibrosis by successively performing full inspiration then full expiration volumetric MR acquisitions using a VIBE - Volumetric Interpolated Breath-hold examination sequence. Post processing of the 2 volumes using elastic registration is performed to evaluate pulmonary deformation in the normal and fibrotic lung areas, hypothesizing that it would be different.
NCT03207997 — Scleroderma
Status: Completed
http://inclinicaltrials.com/scleroderma/NCT03207997/
A Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)
The purpose of this study is to assess feasibility, safety and preliminary efficacy of Brentuximab vedotin (Adcetris), a CD30-directed antibody-drug conjugate, in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc).
NCT03198689 — Diffuse Cutaneous Systemic Sclerosis
Status: Completed
http://inclinicaltrials.com/diffuse-cutaneous-systemic-sclerosis/NCT03198689/
Feasibility Trial of an Internet-based Exercise Program to Improve Hand Function in Patients With Scleroderma: A Scleroderma Patient-centered Intervention Network (SPIN) Study
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are (1) to assemble a large cohort of scleroderma patients to complete outcome assessments regularly in order to learn more about important problems faced by people living with scleroderma and (2) to develop and test a series of internet-based interventions to help patients manage aspects of scleroderma, including hand limitations. In the SPIN-HAND feasibility trial, SPIN Cohort participants with at least mild hand function limitations and an indicated interest in using an online hand exercise program will be randomized to be offered the SPIN hand exercise program or to usual care only. The core SPIN hand exercise program consists of 4 modules that address specific aspects of hand function, including Thumb Flexibility and Strength; Finger Bending; Finger Extension; and Wrist Flexibility and Strength. The program also integrates tools to support key components of successful self-management programs, including goal-setting. The aim of the SPIN-HAND feasibility study is to collect data to assess the feasibility of the steps that need to take place as part of the main trial; required resources; and scientific aspects (e.g., withdrawal rate, outcomes measures). Data will be used to determine whether it is feasible to carry out the main study or whether changes need to be made before conducting a full-scale RCT of the SPIN-HAND program.
NCT03092024 — Systemic Sclerosis
Status: Completed
http://inclinicaltrials.com/systemic-sclerosis/NCT03092024/
A Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital Ulcers
The primary objective of this study is to provide preliminary data on the efficacy (digital ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to placebo in patients with scleroderma-associated digital ulcers
NCT02915835 — Scleroderma
Status: Completed
http://inclinicaltrials.com/scleroderma/NCT02915835/