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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05169086
Other study ID # RECHMPL21_0620
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date January 20, 2022

Study information

Verified date April 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is a cohort study of patients at the University Hospital during the first two days of intensive treatment. The patients are randomly divided into two groups (N=10). Throughout the study, group A is treated with the multilayer elastic bandage while group B is bandaged with contention only. The bandages were applied on the first and second day and were maintained in place. The bandages were applied on the first and second day and were maintained for 24 hours. All patients performed 30 minutes of physical activity in the bandage on both days. The evaluation is based on the volumetric difference, skin quality and quality of life of these patients


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 20, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Adult with unilateral lower limb lymphoedema - Stage 2 or 3 lymphoedema - 1st intensive decongestant treatment - Ability to sit on a cycloergometer Exclusion criteria: - Severe cardiac disease - Infectious dermoepidermitis - Bandage unbearable for the patient

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perimetry of the affected limb The physiotherapist measures the perimeter of the limb with a tape measure day 1
Primary Perimetry of the affected limb The physiotherapist measures the perimeter of the limb with a tape measure Day 2
Primary Volumetry of the affected limb the volume is calculated using computer software. day 1
Primary Volumetry of the affected limb the volume is calculated using computer software. Day 2
Secondary Quality of life questionnaire The patient completes the Lymphoedema Quality of Life Questionnaire (LYMQUOL leg) on admission to the ward and by email one month later day 1
Secondary Quality of life questionnaire The patient completes the Lymphoedema Quality of Life Questionnaire (LYMQUOL leg) on admission to the ward and by email one month later one month later
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