Comparison of Two Types of Bandages in the Treatment of Lymphoedema
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
1 other identifier
observational
20
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
December 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedApril 12, 2022
April 1, 2022
2 months
November 17, 2021
April 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Perimetry of the affected limb
The physiotherapist measures the perimeter of the limb with a tape measure
day 1
Perimetry of the affected limb
The physiotherapist measures the perimeter of the limb with a tape measure
Day 2
Volumetry of the affected limb
the volume is calculated using computer software.
day 1
Volumetry of the affected limb
the volume is calculated using computer software.
Day 2
Secondary Outcomes (2)
Quality of life questionnaire
day 1
Quality of life questionnaire
one month later
Eligibility Criteria
The study population corresponds to patients with primary or secondary lymphedema receiving intensive decongestant treatment at the Montpellier University Hospital. Patients must be of legal age and have unilateral stage 2 or 3 lymphedema.
You may qualify if:
- Adult with unilateral lower limb lymphoedema
- Stage 2 or 3 lymphoedema
- st intensive decongestant treatment
- Ability to sit on a cycloergometer
You may not qualify if:
- Severe cardiac disease
- Infectious dermoepidermitis
- Bandage unbearable for the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uhmontpellier
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
nicolas Erdocio, student
University Hospital, Montpellier
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2021
First Posted
December 23, 2021
Study Start
November 1, 2021
Primary Completion
January 1, 2022
Study Completion
January 20, 2022
Last Updated
April 12, 2022
Record last verified: 2022-04