Creating a tool to evaluate treatment effects in lower limb lymphedema patients
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of an Evaluation Set for Patients With LLL
This study is testing a new tool to help doctors measure how well treatments work for people with swelling in their legs due to lymphedema.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Leuven and 1 other locations) |
| Trial ID | NCT06038864 on ClinicalTrials.gov |
What this trial studies
This research focuses on developing a clinical screening and diagnostic tool to measure the effects of decongestive treatment on lower limb lymphedema. It aims to establish reliable methods for assessing various edema characteristics, such as limb volume and skin hardness, which are crucial for evaluating treatment outcomes. By identifying the key characteristics that need to be measured, the study seeks to improve the accuracy of treatment effect assessments and reduce bias in clinical evaluations. The study involves two clinical evaluations spaced one month apart to gather comprehensive data on treatment effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with unilateral or bilateral lower limb lymphedema who are either starting or have recently completed intensive decongestive lymphatic therapy.
Not a fit: Patients with chronic venous insufficiency or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could lead to more accurate assessments of treatment effectiveness for patients with lower limb lymphedema.
How similar studies have performed: While the approach of developing measurement tools for lymphedema treatment evaluation is not widely tested, similar studies in other areas of edema management have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intensive treatment group * Unilateral or bilateral, primary or secondary LLL * No active metastases * If cancer-related lymphedema, time interval since surgery/ radiotherapy/ chemotherapy is ≥3 months * Objective diagnosis of lymphedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of ICG dermal backflow * Age ≥ 18 years * Able to read, understand and speak Dutch * Planned to start with intensive decongestive lymphatic therapy at one or both legs * Maintenance treatment group * See inclusion criteria 'intensive treatment group' * But: instead of patients planned to start with intensive lymphatic therapy, patients of this group should have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy) Exclusion Criteria: * Pregnant participants * Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome * Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion
Where this trial is running
Leuven and 1 other locations
- University Hospitals of Leuven — Leuven, Belgium (Recruiting)
- Nij Smellinghe Hospital — Drachten, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Tessa De Vrieze, Dr. — KU Leuven
- Study coordinator: Tessa De Vrieze, Dr.
- Email: tessa.devrieze@kuleuven.be
- Phone: 003216345006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.