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
Verified date | April 2022 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | Uhmontpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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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