Creating a Clinical Tool to Screen, Diagnose, and Evaluate Patients with Lower Limb Lymphedema Focus on Measuring Treatment Effects and Changes in Edema Characteristics

What this Trial Is About

Researchers are investigating how to best measure changes in swelling and other characteristics of lower limb lymphedema after treatment. This study aims to identify which tools can reliably detect meaningful changes in edema features such as limb volume, skin hardness, and water content during intensive and maintenance treatment phases. Understanding these measurement criteria is important to accurately assess patient progress and treatment effects. Participants include patients with lower limb lymphedema who are either about to start intensive decongestive lymphatic therapy or are in the maintenance phase after completing intensive treatment at least three months prior. Each participant will undergo two clinical evaluations spaced one month apart using a set of reliable and feasible measurement methods selected by experts. These assessments will focus on various edema characteristics to evaluate treatment effects. During the study, participants will be evaluated on limb volume, skin hardness, pitting status, skinfold thickness, extracellular fluid, and functional problems related to lymphedema. The main outcomes measured are the sensitivity, specificity, and diagnostic accuracy of these evaluation methods after one month. This observational study will help establish clear criteria for clinical changes in lower limb lymphedema, supporting better treatment evaluation and patient care.

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4