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Scleroderma, Localized clinical trials

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NCT ID: NCT06425653 Completed - Clinical trials for Scleroderma, Systemic

Exercise With Scleroderma Functional Outcomes

Start date: February 5, 2021
Phase: N/A
Study type: Interventional

The study aims to investigate the effects of an exercise program applied to patients with scleroderma on functional outcomes (hand and mouth functional results and quality of life).

NCT ID: NCT05622578 Completed - Clinical trials for Scleroderma, Systemic

Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

PAIN SSc
Start date: October 19, 2022
Phase: N/A
Study type: Interventional

The primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain. As secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which will be associated in a unique questionnaire in order to evaluate the pain, the fatigue and the sleeping disorders in diffused systemic scleroderma patients.

NCT ID: NCT05171114 Completed - Clinical trials for Scleroderma, Systemic

Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

SCLERO-HAND
Start date: December 28, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.

NCT ID: NCT05080738 Completed - Scleroderma Clinical Trials

Upper Extremity Home Exercises in Patients With Scleroderma

Start date: September 10, 2021
Phase: N/A
Study type: Interventional

Hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. The vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. Literature indicate that more work is needed to continue to develop and evaluate rehabilitation interventions in this population. This study is a randomized controlled study examining the effects of 8 weeks of upper extremity home exercises on grip strength, normal joint movement, activity performance and functionality in patients with scleroderma. In our study, it is aimed to contribute to the standardization of upper extremity exercise protocols for scleroderma patients, to increase the quality of life of patients and to increase their independence in daily living activities.

NCT ID: NCT04908943 Completed - Scleroderma Clinical Trials

RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue

RENEW
Start date: August 28, 2021
Phase: N/A
Study type: Interventional

The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.

NCT ID: NCT04752397 Completed - Clinical trials for Graft Vs Host Disease

The Influence of Extracorporeal Photopheresis on Skin Sclerosis

Start date: February 12, 2021
Phase:
Study type: Observational

Extracorporeal photopheresis (ECP), also known as extracorporeal photoimmunotherapy or photochemotherapy, is a leukapheresis-based therapy that has been in clinical use for over three decades after receiving FDA approval in 1988. Extracorporeal photopheresis was initially used for the treatment of T-cell lymphoma. Since its introduction, indications for initiating ECP were continuously extended to the treatment of Graft-versus-Host Disease (GvHD), systemic sclerosis, and in the field of solid organ transplantation. There is also evidence supporting the use of ECP in generalized morphea, a form of scleroderma limited to the skin, and in eosinophilic fasciitis, which is a rare, localized fibrosing disorder of the fascia. Concluding the results of the published studies, there is evidence that ECP has a positive effect on fibrosing disorders of the skin. Furthermore, in clinical practice, it has been observed that patients with systemic sclerosis, who undergo ECP treatment, show improvement of the skin lesions or a deceleration in the formation progress of such lesions during the therapy. Same findings can be observed in patients with sclerotic skin lesions of the skin, for example in the context of a GvHD. There are no clinical studies so far that describe these processes using objective measuring methods. Furthermore, the mechanism of action of ECP in systemic sclerosis and other fibrosing disorders with skin manifestations, has not yet been conclusively clarified. Serological markers for monitoring the progress of the therapy and determining the prognosis are also missing. Thus, a consensus regarding the frequency and duration of ECP for the therapy of systemic scleroderma or sclerotic diseases has not yet been reached. This study aims at evaluating the influence of Extracorporeal Photopheresis on the quality and functionality of sclerotic skin lesions assessed by several objective methods. Furthermore, potential biomarkers, which are being investigated in current studies, are to be determined in order to evaluate the influence of ECP on those biomarkers and better understand the mechanism of action of ECP on systemic sclerosis and fibrosing disorders involving the skin.

NCT ID: NCT04684225 Completed - Rehabilitation Clinical Trials

Telerehabilitation on Hand-Affected Scleroderma

Start date: January 6, 2021
Phase: N/A
Study type: Interventional

Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma

NCT ID: NCT04647890 Completed - Clinical trials for Scleroderma, Systemic

Effects of FT011 in Systemic Sclerosis

Start date: July 19, 2021
Phase: Phase 2
Study type: Interventional

FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).

NCT ID: NCT04523506 Completed - Scleroderma Clinical Trials

The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma

Start date: May 8, 2020
Phase: Early Phase 1
Study type: Interventional

This study will evaluate the use of botulinum toxin for microstomia (also known as reduced oral aperture) in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1-3. The study will include three arms: the temporomandibular joint (TMJ) group who will receive injections of Botox to the masseter, the perioral group who will receive injections of Botox around the lips, and a control group who will receive no treatment for ROA. Outcome measurements will include measurement of oral aperture size through measurement inter-labial distance and between the upper and lower lips and the inter-incisal distance, patient satisfaction via a Skindex16 survey, mouth disability via the Mouth Handicap in Systemic Sclerosis Scale (MHISS), and patient and physician satisfaction using the Visual Analogic Scale (VAS). The maximum number of subjects to be consented for this study is 30. The study is expected to last four months per subject from time of consent to last clinical evaluation. Conditions that may result in a subject exiting the study prior to completion date include non-compliance, withdrawal of consent, or safety concerns such as adverse events as a result of treatment.

NCT ID: NCT04335279 Completed - Systemic Sclerosis Clinical Trials

Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program

SPIN-CHAT
Start date: April 9, 2020
Phase: N/A
Study type: Interventional

Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks. Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (> 40% have interstitial lung disease) and common use of immunosuppressant drugs. The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support.