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

NCT06038864 | Recruiting

• 1 other identifier: s66033-aim4
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation. To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects. First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high. Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?

Conditions

Lower Limb Lymphedema

Keywords

lymphedema; measurement; clinical evaluation

Outcome Measures

Primary Outcomes (3)

• Sensitivity of measurement methods

  Sensitivity of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.

  1 month

• Specificity of measurement methods

  Specificity of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.

  1 month

• Diagnostic accuracy of measurement methods

  Diagnostic accuracy (in terms of area under the curve using a ROC curve, as well as sensitivity and specificity) of measurement methods (resulting from aim 1:NCT05269264) in the evaluation of the treatment effect over time in patients with unilateral and bilateral LLL. Patients will be evaluated twice with 1 month in between.

  1 month

Secondary Outcomes (6)

• Lymphedema volume after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL

  1 month

• Hardness of skin after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL

  1 month

• Piiting status after 4 weeks f intensive DLT in patients with unilateral and bilateral LLL

  1 month

• Skinfold thickness after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL

  1 month

• Extracellullar fluid after 4 weeks of intensive DLT in patients with unilateral and bilateral LLL

  1 month

Study Arms (2)

Intensive group

Patients with lower limb lymphoedema planned for intensive treatment

Diagnostic Test: 2 clinical evaluations with 1 month in between

Maintenance group

Patients with stable lower limb lymphoedema who are in the maintenance phase (at least 3 months)

Diagnostic Test: 2 clinical evaluations with 1 month in between

Interventions

2 clinical evaluations with 1 month in between DIAGNOSTIC_TEST

Patients will be evaluated twice with all evaluation methods selected by the international expert group (cfr. aim 1) showing sufficient reliability and feasibility in the patient group with LLL from aim 1

Intensive group; Maintenance group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive treatment group: Patients planned to start with intensive decongestive lymphatic therapy at one or both legs. Maintenance treatment group: patienst who have ended their intensive treatment phase at least 3 months ago (= currently receiving maintenance decongestive lymphatic therapy)

You may qualify if:

• 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
• 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)

You may not qualify if:

• Pregnant participants
• Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Nij Smellinghe Hospital Drachten: collaborator

Study Sites (2)

University Hospitals of Leuven

Leuven, 3000, Belgium

RECRUITING

Nij Smellinghe Hospital

Drachten, 9202, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Tessa De Vrieze, Dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tessa De Vrieze, Dr.

CONTACT

003216345006; tessa.devrieze@kuleuven.be

Nele Devoogdt, Prof. Dr.

CONTACT

0032 16 342515; nele.devoogdt@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 15, 2023
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (1); BE (1)