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Lipedema clinical trials

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NCT ID: NCT06399367 Enrolling by invitation - Lymphedema Clinical Trials

Investigation of Lipedema, Lymphedema and Vascular Malformations by Multispectral Optoacoustic Tomography (MSOT)

Start date: August 2024
Phase:
Study type: Observational

This study aims to analyze the fatty tissue architecture of the subcutaneous tissue in patients from the plastic surgery department. Plastic surgery patients show a wide variety of subcutaneous fatty tissue structures during clinical examination. These include patients with edema of the extremities such as lipedema or lymphedema. Fatty tissue architecture plays a major role in our everyday lives, as wound healing and scar formation, for example, are influenced by the blood flow to the overlying skin. The fatty tissue architecture, especially in the subcutaneous fatty tissue, also plays a major role in our appearance. An analysis of the architecture can potentially provide information about the genesis of different skin fold formations. The aim of this study is to quantitatively describe structural differences in adipose tissue architecture. Adipose tissue architecture is still a largely unexplored area because imaging has not been possible to date. MSOT imaging is similar to conventional sonography in that a transducer is placed on the skin and energy is supplied to the tissue by pulsed laser light instead of sound. On a macroscopic level, this leads to a constant change of minimal oscillations of individual tissue components. The resulting sound waves can then be detected by the same transducer. Previous studies have shown that the quantitative determination of hemoglobin can be used to obtain information on blood circulation and inflammatory activity. In the extended spectrum, in contrast, not only hemoglobin and its oxygenation stages but also other biomarkers such as collagens and lipids can be detected. This is very useful for imaging of fat, lymphatics and normal and abnormal blood vessels in vascular malformations. This process was largely researched by the working group of Prof. Ntziachristos (Helmholtz Center Munich and Technical University of Munich) and Prof. Razansky (Eidgenösische Technische Hochschule Zurich) and is being further developed into a clinically applicable technology and sold commercially by the company iThera. As a first series of demonstrative clinical studies following rigorous technical development, MSOT will serve as a key tool for research partners in the investigation of several diseases that remain poorly-understood and have limited treatment options. These parallel studies will focus on lipedema and lymphedema as well as vascular malformations - three distinct disease groups with similarly unmet clinical needs for appropriate imaging modalities and high potential of translation to further major disease areas. By focusing on two unrelated diseases, this project will show the wide-reaching application of this innovative imaging approach. Following successful proof-of-principle validation in a clinical research environment, full exploitation and dissemination of the results will strive to deliver MSOT to the greater scientific community. The main objectives are to confirm/validate the spectral profile of fat and vasculature on MSOT in lipedema patients, to establish the spectral profile of vascular malformations based on MSOT for adults and children and to establish the spectral profile and imaging of lymphatic vessels. With a detailed analysis of the architecture, our understanding of the physiology and pathology of the skin may be enhanced.

NCT ID: NCT06338059 Active, not recruiting - Clinical trials for Vitamin D Deficiency

Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema

Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema.

NCT ID: NCT06238791 Completed - Clinical trials for Chronic Venous Insufficiency

Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease

Start date: October 5, 2023
Phase:
Study type: Observational

Chronic venous disease (CVD) are common vascular pathology characterized by a wide spectrum of clinical manifestations occurring with symptoms and/or signs that vary in type and severity. The pathophysiological mechanisms of CVD start from the development of venous hypertension, leading to endothelial dysfunction and venous wall dilatation. Lipedema is subcutaneous adipose tissue disorder characterized by enlargement of both lower extremities. Previous studies showed that foot deformities such as pes planus or cavus are at a high prevalence in CVD patients, and the authors indicated that foot disorders are an important risk factor that negatively affects venous disease. To the best of our knowledge, there is only one study investigating plantar arch abnormalities in lipedema patients based on clinical observation. Therefore, the study aimed to investigate plantar foot distribution and foot deformity in patients with CVD and lipedema.

NCT ID: NCT06196619 Completed - Pain Clinical Trials

The Relationship of Shear Wave Elastography Findings With Pain Threshold and Quality of Life in Patients With Lipedema

Start date: April 1, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to evaluate the relationship between disease severity and subcutaneous tissue shearwave elastography findings with pain threshold and quality of life in patients diagnosed with lipedema.

NCT ID: NCT06180850 Recruiting - Lipedema Clinical Trials

Building Lipedema Research Resources

BRR
Start date: February 23, 2024
Phase:
Study type: Observational [Patient Registry]

Lipedema is a disease marked by subcutaneous adipose tissue accumulation in the lower extremities of females that is accompanied by somatic pain and edema. Importantly, lipedema is commonly misdiagnosed as obesity, although it's estimated to affect a high 11% of women. Clinical diagnosis of lipedema requires specialized training not widely available at most major medical centers, and there remains a substantial need for objective tools to distinguish lipedema from obesity. There is a critical need to define specific molecular markers of disease in circulation or at the tissue-level. The purpose of this study is to create, manage, and characterize an innovative lipedema biorepository. The goal of the biorepository will be to better understand disease mechanisms of lipedema and to define specific molecular markers of disease in circulation or at the tissue-level. The long-term purpose of our studies are to help with prevention and early management of lipedema.

NCT ID: NCT05966779 Completed - Vascular Diseases Clinical Trials

Physical Therapy in Lipedema Surgery

Start date: July 1, 2023
Phase:
Study type: Observational

The goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery. The main question it aims to answer are: - if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days - if the treatment is effective on preventing complications of these participants after surgery Participants have been treated in the lasts years and authors recover information of the effects of the treatment. Researchers will compare sub-groups of participants depending on the number of physical therapy sessions received

NCT ID: NCT05944796 Not yet recruiting - Lipedema Clinical Trials

Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema

EDRTASAL
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

Diathermy, a therapy that uses deep heat to reach deep tissue layers, is known to induce the breaking down of fatty cells and fibrotic tissue. In lipedema, patients develop fibrosis of their subcutaneous adipose tissue. Therefore, diathermy could be an interesting tool to treat this disease. To test the effectiveness of diathermy on these patients, the investigators will select women with lipedema (18 to 70 yo) and place them in two groups (experimental and control group). The experimental group will receive the treatment, that is, 10 minutes of diathermy on the medial knee surface of both knees, with an intensity that produces heat just below the participants' pain threshold. Participants from the control group will receive sham diathermy, that is, placebo. The intervention consists of 10 sessions, 3 times a week, for 4 weeks. Researchers will collect data pre and post intervention and one month after the intervention ends. Data will consist of measurements at knee level with tape and an ultrasound device, pain threshold with an algometer, a VAS score and an SF-12 questionnaire for quality of life.

NCT ID: NCT05861583 Recruiting - Lipedema Clinical Trials

Evaluation of Lipoedema Tissue Transcriptome

Start date: January 1, 2023
Phase:
Study type: Observational

Lipoedema is a chronic painful disease with a fat distribution disorder affecting women. It is probably aggravated by hormonal changes. It is also discussed that a genetical predisposition might be a risk factor for developing lipoedema. The mechanisms leading to lipoedema are mostly unknown. The aim of this study is to identify molecular mechanisms and changes of the RNA-Expression pattern causing lipoedema by comparing the transcriptome of subcutaneous tissue of lipoedema patients vs. healthy subcutaneous tissue.

NCT ID: NCT05739279 Recruiting - Sarcopenia Clinical Trials

Sarcopenia and Related Factors in Lipedema

Start date: January 1, 2023
Phase:
Study type: Observational

Lipedema is a common disease of subcutaneous adipose tissue. The most common complaint of patients with swelling in the affected extremity is pain. In addition, patients with lipedema may experience conditions that can greatly affect the health and quality of life of the individual, such as loss of muscle strength and exercise capacity, and deterioration in activity levels of daily living. It is still unknown whether the decrease in muscle strength in patients with lipedema is part of this condition or whether decreased activity levels lead to decreased muscle strength. Sarcopenia is an important health problem characterized by age-related loss of muscle mass and muscle function. The relationship between muscle weakness and sarcopenia in patients with lipedema has not been investigated before. Early recognition of possible sarcopenia and functional limitations in these patients may be important to increase the ability of patients to participate in physical activity as part of their conservative management. There is no study in the literature investigating sarcopenia in patients with a diagnosis of lipedema. The aim of this study is to evaluate patients with a diagnosis of lipedema in terms of sarcopenia. In addition, the relationship between sarcopenia and age, body mass index, exercise frequency, lipedema type, and stage will be investigated in patients diagnosed with lipedema.

NCT ID: NCT05628948 Recruiting - Clinical trials for Cardiovascular Diseases

Vascular Lab Resource (VLR) Biorepository

Start date: November 14, 2019
Phase:
Study type: Observational

This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.