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Completed

NCT Number: NCT05169086

Comparison of Two Types of Bandages in the Treatment of Lymphoedema

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

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Key information

Conditions

Lymphoedema Chronic Disease Disease Attributes Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Perimetry of the affected limb

    Time frame: day 1

    The physiotherapist measures the perimeter of the limb with a tape measure

  2. Perimetry of the affected limb

    Time frame: Day 2

    The physiotherapist measures the perimeter of the limb with a tape measure

  3. Volumetry of the affected limb

    Time frame: day 1

    the volume is calculated using computer software.

  4. Volumetry of the affected limb

    Time frame: Day 2

    the volume is calculated using computer software.

Secondary outcomes

  1. Quality of life questionnaire

    Time frame: day 1

    The patient completes the Lymphoedema Quality of Life Questionnaire (LYMQUOL leg) on admission to the ward and by email one month later

  2. Quality of life questionnaire

    Time frame: one month later

    The patient completes the Lymphoedema Quality of Life Questionnaire (LYMQUOL leg) on admission to the ward and by email one month later

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2021
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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