ULTRASONOGRAPHIC EVALUATION OF LOWER EXTREMITY SKIN AND SUBCUTANEOUS TISSUE WITH QUANTITATIVE ECHOGENICITY AND ELASTOGRAPHY IN LYMPHEDEMA, LIPEDEMA, AND HEALTHY CONTROL GROUPS: A CONTROLLED CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Dermal and Subcutaneous Tissue Thickness
研究概览
简要总结
The aim of this observational study is to evaluate the diagnostic value of multimodal ultrasonography in differentiating between lymphedema and lipedema. Differentiating these two chronic conditions based solely on clinical examination can be challenging due to overlapping symptoms. This study will utilize various non-invasive ultrasound techniques-including B-mode ultrasound, strain elastography, power Doppler, and quantitative ImageJ analysis-to compare tissue characteristics among patients with lymphedema, patients with lipedema, and healthy controls. The goal is to identify reliable, non-invasive imaging biomarkers that can facilitate early and accurate diagnosis, thereby optimizing patient management.
详细描述
Lymphedema and lipedema are distinct pathological entities that often present with similar clinical features, particularly in the lower extremities. Accurate differential diagnosis is crucial for appropriate therapeutic intervention. While modalities like lymphoscintigraphy serve as standard diagnostic tools for lymphedema, they are invasive and not universally accessible. High-resolution ultrasonography provides a practical, non-invasive alternative for tissue assessment.
This cross-sectional, observational study will recruit participants and categorize them into three groups: a lymphedema group, a lipedema group, and a healthy control group. Comprehensive multimodal ultrasound evaluations will be performed on all participants. The assessment protocol includes:
B-mode Ultrasonography: To measure the thickness of the dermis and subcutaneous tissue layers.
Strain Elastography: To evaluate the biomechanical properties and relative stiffness of the affected tissues.
Power Doppler: To assess the local microvascularity and blood flow patterns.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18 to 75 years.
- •Clinical diagnosis of lower extremity lymphedema (for the lymphedema group).
- •Clinical diagnosis of lower extremity lipedema (for the lipedema group).
- •Healthy individuals with no history or clinical signs of chronic lower extremity edema (for the control group).
排除标准
- •Presence of active local infections, such as cellulitis or erysipelas, in the lower extremities.
- •History of deep vein thrombosis (DVT) or severe chronic venous insufficiency.
- •Systemic conditions that can cause secondary edema, including congestive heart failure, chronic kidney disease, or severe hepatic impairment.
- •Previous surgical interventions on the affected lower extremities, including liposuction, lymphatic reconstructive surgery, or major orthopedic surgeries.
- •Active malignancy or currently undergoing radiotherapy/chemotherapy.
- •Pregnancy or lactation.
结局指标
主要结局
Dermal and Subcutaneous Tissue Thickness
时间窗: Day 1 (At the time of ultrasound assessment)
Measurement of the dermal and subcutaneous tissue layers in millimeters (mm) using high-resolution B-mode ultrasonography to identify anatomical differences between the groups.
次要结局
- Tissue Stiffness Assessment via Strain Elastography(Day 1 (At the time of ultrasound assessment))
- Quantitative Echogenicity Analysis(Day 1 (At the time of ultrasound assessment))
- Visual Analogue Scale (VAS) for Pain(Day 1 (Baseline clinical evaluation))
研究者
Ayse Guc
Uz. Dr.
Kayseri City Hospital