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Systemic Sclerosis clinical trials

View clinical trials related to Systemic Sclerosis.

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NCT ID: NCT06231433 Completed - Systemic Sclerosis Clinical Trials

Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis

SCLERDERMCO2
Start date: May 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days. At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.

NCT ID: NCT06095921 Completed - Systemic Sclerosis Clinical Trials

The Effect of a Self-Management Program on Individuals With Scleroderma

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Introduction: Individuals with systemic sclerosis (SSc) have problems with perceived occupational performance and satisfaction in daily life activities due to many symptoms caused by the disease. Purpose: This study will plan to examine the effect of a self-management program for individuals with SSc on perceived occupational performance and satisfaction. Materials and Methods : Twenty-nine individuals with SSC, 28 females and 1 male will participate in the study. Perceived occupational performance and satisfaction levels before and after the program will evaluate with the Canadian Ocupational Performance Measure (COPM). The training programme will design according to the activities of COPM, the needs of the patients, and the literature. The programme consists of 8 sessions for 8 weeks, 1 day a week for 45 minutes.

NCT ID: NCT05907200 Completed - Systemic Sclerosis Clinical Trials

Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The objective of this before-after non-randomized trial study is to evaluate the efficacy of ultrasound therapy in combination with manual therapy in the management of systemic sclerosis patients with IDU. The main questions it intends to answer are: • Is this combination of treatments effective in these patients in terms of improvement in hand functional ability, pain relief, injury healing, and quality of life? Participants will receive rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping, and connective tissue massage) and US water immersion. The researchers will compare the group of participants, called the treatment group, with a control group to see if: • Is the combined treatment of ultrasound therapy and manual therapy more effective in these patients than manual therapy alone?

NCT ID: NCT05453071 Completed - Systemic Sclerosis Clinical Trials

The Effect of Cognitive Exercise Therapy Approach in Individuals With Systemic Sclerosis

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of Cognitive Exercise Therapy Approach (BETY) on vascularization, muscle strength, functionality, anti-inflammatory and biopsychosocial status in individuals with systemic sclerosis and to present a named exercise model for this disease group with objective results.

NCT ID: NCT04854850 Completed - Fatigue Clinical Trials

Apollo Device for Fatigue in Systemic Sclerosis

Start date: July 7, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to learn about the effect of Apollo (a vibrating wearable about the side of an Apple Watch) on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic sclerosis. SSc patients frequently have fatigue as a characteristic feature of their disease and fatigue negatively impacts quality of life (Haythornthwaite 2003, Richards 2003, Suarez-Almazor 2007, Basta 2017). The prevalence of fatigue among SSc patients is 75%, with 61% ranking fatigue among their top three most distressing complaints. Fatigue is also associated with poor sleep quality, greater pain and depressive symptoms (Sandusky 2009). We hypothesize that treatment with Apollo over 1 month will improve fatigue. If successful, the Apollo technology will be the first treatment option for fatigue and Raynaud's in this population.

NCT ID: NCT04826419 Completed - Systemic Sclerosis Clinical Trials

Effect of Ozone Therapy for the Treatment of Digital Ulcer in Patients With SSc

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Functionality in patients with SSc? Systemic Sclerosis (SSc) is a chronic connective tissue disease characterized by microvascular involvement, immunological dysfunction, extracellular matrix deposition in the skin and internal organ involvement. Vascular disease has an important role in the pathogenesis of SSc. Especially as a result of involvement of micro-vessel and digital arteries, digital ulcer (DU) formation may be seen. DUs are responsible for pain, poor quality of life, impairment of life activities and morbidity in patients with SSc. , they are correlated to disease severity and outcome. Approximately half of SSc patients have DU during the course of the disease. Recurrent DU is observed in 10% of the patients. In 75% of these patients, DU occurs 5 years after diagnosis. Patients with anti-SCL 70+ develop DU 5 years earlier than those with anti-centromere positive. The development of DU may take a long time to heal if there is underlying calcinosis. In a study, it was seen that the recovery of DU was 93.6 days if there is underlying calcinosis, and 76.2 days if not. DUs can be infected and thus complicated by osteomyelitis. In a retrospective study, it was reported that 42% of infected DUs were associated with osteomyelitis. DU management is a great challenge for the clinician and requires a multidisciplinary approach. Ozone has a place in medical use since the 19th century, as it is an oxidant and disinfectant. In recent studies, it has been reported to be antiviral and bactericidal. Therefore, it has indications such as coronary artery disease, chronic hepatitis and chronic low back pain. It has also been shown to have a positive role in trophic ulcer, ischemic ulcer and diabetic ulcer healing. The mechanism by which ozone therapy provides wound healing is not fully understood. In addition, it improves microcirculation in the capillary vessels by improving flexibility and stability of the cell membrane and limiting the aggregation and adhesion of platelets. In the literature, it was stated in a study that ozone therapy was effective for the treatment of DU in SSc patients. In our study, we aimed to investigate the effect of ozone therapy on patients who are resistant to medical treatment and who have impaired quality of life for a long time.

NCT ID: NCT04744207 Completed - Systemic Sclerosis Clinical Trials

A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis

Start date: December 29, 2020
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the safety, and evaluate the efficacy of GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).

NCT ID: NCT04725786 Completed - Systemic Sclerosis Clinical Trials

Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study

PRECOSS
Start date: March 17, 2021
Phase: N/A
Study type: Interventional

Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis is essential to optimize this management. Current diagnostic techniques are based on high-resolution computed tomography on the thorax (HRCT) and pulmonary functional tests (PFT). However, these explorations have their limitations. Thus, there is a need for new techniques for a very early diagnosis of PID-SSc. Thoracic ultrasound (TUS) is an innovative, easily accessible, non-irradiating, inexpensive and painless tool. It is an emerging technique for the diagnosis of PID and has already proven its sensitivity for the detection of interstitial damage, as defined by HRCT. The main objective of the PRECOSS study is to describe the prevalence of an ultrasound interstitial syndrome in patients with SSc, free of PID-SSc (defined by the Goh criteria) detectable by HRCT.

NCT ID: NCT04675502 Completed - Systemic Sclerosis Clinical Trials

Effects of a Supervised Exercise Program and a Home Exercise Program in Patients With Systemic Sclerosis

Start date: June 10, 2018
Phase: N/A
Study type: Interventional

Scleroderma, also called systemic sclerosis (SSc); It is a heterogeneous multiorgan disease of unknown etiology characterized by vasculopathy, autoimmunity and fibrous tissue. It is stated in studies that cardiac and pulmonary systems are affected in patients with SSc and these effects affect the aerobic capacity, physical functions and quality of life of patients negatively by disrupting their pulmonary and musculoskeletal functions. However, considering the treatment approaches in scleroderma patients, the number of studies evaluating the effectiveness of pulmonary rehabilitation and exercises is limited. Therefore, the purpose of our study; Comparison of the effects of a supervised exercise program and a home exercise program in patients with Systemic Sclerosis.

NCT ID: NCT04532151 Completed - Systemic Sclerosis Clinical Trials

Optical Coherence Tomography Imaging in Systemic Sclerosis

OCTISS
Start date: February 2, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is an autoimmune disorder characterized by early vascular endothelial involvement. SSc is a rare and devastating multi-visceral disease when fibrotic lesions extend to the skin and other tissues (heart, lungs, kidneys). The severity of skin involvement in SSc is correlated with functional prognosis and survival. To date, there is no validated tool for a reliable quantitative assessment of skin fibrosis. Optical coherence tomography (OCT) is an innovative non-invasive skin imaging technique that allows micrometric analysis of the superficial layers of the skin. Previous study showed that OCT could detect the loss of the dermal-epidermal junction in an objective and non-invasive way, which is correlated with severity of skin fibrosis. The aim of OCTISS study is to evaluate the skin involvement of patients with early SSc using OCT imaging. This will be early diagnosis of fibrosis lesions and help identify patients at an early stage.