NCT05169086

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

November 17, 2021

Last Update Submit

April 11, 2022

Conditions

Keywords

LymphologyChronic diseasereduction bandages

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

LymphedemaChronic Disease

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • nicolas Erdocio, student

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

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

Locations