Comparison of Two Types of Bandages in the Treatment of Lymphoedema

Lymphoedema Clinical Trial

Official title:

The Effectiveness of the Elastic Component of the Multilayer Bandage in the Treatment of Patients With Lymphedema at the University Hospital of Montpellier : a Randomised Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05169086
• Other study ID #: RECHMPL21_0620
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Lymphedema
• Lymphoedema

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