Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03492476
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
medi
Information provided by (Responsible Party):
CEN Biotech

Brief Summary:

One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and experience to exert the pressure required to remove liquids from tissue spaces and reduce the volume of the arm or prevent it from increasing again.

The study aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.


Condition or disease Intervention/treatment Phase
Lymphedema of Upper Arm Device: Circaid Device: Short-stretching Bandage (Reference treatment) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled, Randomized Clinical Trial of the Circaid® Compression Sleeve Versus Short-stretching Bandage at the Reduction Phase of Upper Limb Lymphatic Edema and Versus Compression Sleeve and Short-stretching Bandages at the Initial Maintenance Phase
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Lymphedema

Arm Intervention/treatment
Experimental: Circaid
Compression sleeve on the day associated with the night wearing of the system of contention circaid®
Device: Circaid

Three observation periods were defined with the following products:

  • D1 to D5: intensive hospital treatment performed by the night and day wearing of the circaid® compression system
  • Day of Discharge (DD) from the hospital to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime compression system circaid®
  • DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime circaid® compression system
Other Name: Non-elastic bands

Active Comparator: Reference treatment
Compression sleeve during the day associated with a possible treatment with it during the night, according to the recommendations of the HAS
Device: Short-stretching Bandage (Reference treatment)

Three observation periods were defined with the following products:

  • D1 to D5: intensive hospital treatment performed by the night and day wearing of short stretching tapes.
  • DD (Day of discharge from the hospital) to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with a possible treatment at night, as recommended by HAS.
  • DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with possible treatment at night
Other Name: Non-elastic bands




Primary Outcome Measures :
  1. Volume reduction of upper limb lymphatic edema D30 [ Time Frame: 30 days ]
    The main objective of the study is to compare, at the 30th day of the initial maintenance phase, the reduction in the volume of lymphatic edema of the upper limb obtained under the effect of the wearing of a compression sleeve on the day associated with the night wearing of the system of contention circaid® versus the wearing of a compression sleeve during the day associated with a possible treatment with it during the night, according to the recommendations of the french High Authority of Health (HAS).


Secondary Outcome Measures :
  1. Volume reduction of upper limb lymphatic edema D5 [ Time Frame: 5 days ]
    To compare, on the 5th day of the reduction phase, the reduction in the volume of lymphatic edema of the upper limb obtained under the effect of the night and day wearing of the circaid® compression system and the night and day wearing of short lengthening bands such as recommended by the HAS

  2. Volume reduction of upper limb lymphatic edema D90 [ Time Frame: 90 days ]
    To compare, at the 90th day of the maintenance phase, the reduction in the volume of lymphatic edema maintained by the wearing of a compression sleeve during the day associated with the circaid® compression system at night and the wearing of a compression sleeve during the day associated with a possible wearing at night.

  3. Physician's opinion on lymphedema-induced discomfort improvement D5 (Clinical Global Improvement Impression) [ Time Frame: 5 days ]
    To compare, at the 5th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the Clinical Global Improvement Impression (CGII). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".

  4. Patient's opinion on lymphedema-induced discomfort improvement D5 (Patient Global Improvement Impression) [ Time Frame: 5 days ]
    To compare, at the 5th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the Patient Global Improvement Impression (PGII). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".

  5. Patient's opinion on lymphedema-induced discomfort improvement D30 (Patient Global Improvement Impression) [ Time Frame: 30 days ]
    To compare, at the 30th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the PGII (Patient Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".

  6. Patient's opinion on lymphedema-induced discomfort improvement D90 (Patient Global Improvement Impression) [ Time Frame: 90 days ]
    To compare, at the 90th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the PGII (Patient Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".

  7. Physician's opinion on lymphedema-induced discomfort improvement D30 (Clinical Global Improvement Impression) [ Time Frame: 30 days ]
    To compare, at the 30th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the CGII (Clinical Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".

  8. Physician's opinion on lymphedema-induced discomfort improvement D90 (Clinical Global Improvement Impression) [ Time Frame: 90 days ]
    To compare, at the 90th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the CGII (Clinical Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".

  9. Patient's adherence to the treatment D30 (Morisky score). [ Time Frame: 30 days ]
    To compare, at the 30th day of the initial maintenance phase the adherence of patients to the wearing of their maintenance treatment. The Morisky score is used : 4 items to be assessed by the patient (Yes/no response).

  10. Patient's satisfaction about efficiency of the treatment D30 (Likert scale) [ Time Frame: 30 days ]
    To compare, at the 30th day of the initial maintenance phase the patient's satisfaction. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all efficient" (worse outcome) to "Very efficient" (better outcome). Intermediate levels are: "A bit"; "Moderately"; "Efficient".

  11. Patient's satisfaction about wearing comfort of the treatment D30 (Likert scale) [ Time Frame: 30 days ]
    To compare, at the 30th day of the initial maintenance phase the patient's wearing comfort experienced. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all comfortable" (worse outcome) to "Very comfortable" (better outcome). Intermediate levels are:"A bit"; "Moderately"; "Comfortable".

  12. Patient's satisfaction about efficiency of the treatment D90 (Likert scale) [ Time Frame: 30 days ]
    To compare, at the 90th day of the initial maintenance phase the patient's satisfaction. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all efficient" (worse outcome) to "Very efficient" (better outcome). Intermediate levels are: "A bit"; "Moderately"; "Efficient".

  13. Patient's satisfaction about wearing comfort of the treatment D90 (Likert scale) [ Time Frame: 90 days ]
    To compare, at the 90th day of the initial maintenance phase the patient's wearing comfort experienced. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all comfortable" (worse outcome) to "Very comfortable" (better outcome). Intermediate levels are:"A bit"; "Moderately"; "Comfortable".

  14. Patient's adherence to the treatment D90 (Morisky score). [ Time Frame: 90 days ]
    To compare, at the 90th day of the initial maintenance phase the adherence of patients to the wearing of their maintenance treatment. The Morisky score is used : 4 items to be assessed by the patient (Yes/no response).

  15. Patient's opinions on the ease of use of the product D90 (6 items to be completed by the patient) [ Time Frame: 30 days ]
    To compare, at the 90th day of the initial maintenance phase the patients' opinions on the ease of use of the product. The patient have to complete 6 items (Yes/no response) : "Did you need caregiver's help ?"; "Did you need a third party to install the device ?"; "Did you have difficulty applying the required pressures ?"; "Do you wish to continue using the device ?"; "Would you recommend this device to third parties ?"; "Does the device seem easy to use ?".

  16. Tolerance of the different products (patient evaluation on self-administered questionnaire) [ Time Frame: 90 days ]
    To compare the tolerance of the different products at different phases of reduction and maintenance. Evaluation item on patient self-administered questionnaire "Intolerance to the device" to be assessed every week (Yes/no response, if yes, the patient have to precise).

  17. Quality of patient's life assessment with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF) [ Time Frame: 90 days ]
    The quality of patient's life is assessed at each visit (D0, D5, D30, D90) with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female only can be recruited.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • be women over the age of 18;
  • presenting a unilateral lymphedema of the upper limb of stage II or III according to the International Society of Lymphology, secondary to the curative ganglion treatment of a cancer, whatever its nature, and requiring a decongestive treatment by contention / compression;
  • presenting an increase in the volume of the arm affected by lymphedema of at least 10% when compared to the contralateral arm;
  • benefiting of the French health insurance coverage;
  • duly informed of the benefits, constraints and risks of the study;
  • medically and legally able to understand the methods of carrying out the study and to give written informed consent to participate in the study;
  • having given their free written informed consent to their participation in the study

Exclusion Criteria:

Not be included in the study:

  • from a medical point of view, the patients:

    • with stage I lymphedema;
    • with lymphedema of multiple locations;
    • having had intensive decongestive treatment in the last 6 months;
    • having a recurrence of cancer or a peripheral arterial disease contraindicating or restraining compression.
  • from a legal point of view, the patients:

    • not in a position to give free and informed consent because of an administrative or judicial decision or a pathology that may affect their judgment or a difficulty of linguistic comprehension;
    • currently participating in another clinical trial or in an exclusion period from another clinical trial;
    • who may not adhere to the terms of the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492476


Contacts
Layout table for location contacts
Contact: ANNE LISE BROCHOT, MME +33380680510 annelise.brochot@groupecen.com
Contact: GEORGES MAYEUX, M. +33380682092 georges.mayeux@groupecen.com

Locations
Layout table for location information
France
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33300
Contact: PASCAL GOUSSE, M.    +33688885005    pascal.gousse@gmail.com   
Principal Investigator: PASCAL GOUSSE, M.         
Chu Saint Eloi Not yet recruiting
Montpellier, France, 34295
Contact: ISABELLE QUERE, PR    +33467337025    i-quere@chu-montpellier.fr   
Contact: SANDRINE MESTRE GODIN, MD    +33467337028    s-mestre@chu-montpellier.fr   
Principal Investigator: ISABELLE QUERE, PR         
Sub-Investigator: SANDRINE MESTRE GODIN, MD         
Ghr Mulhouse Sud Alsace Not yet recruiting
Mulhouse, France, 68070
Contact: AMER HAMADE, MD    +33612357337    hamadea@ghrmsa.fr   
Principal Investigator: AMER HAMADE, MD         
Hopital Cognacq Jay Recruiting
Paris, France, 75015
Contact: STEPHANE VIGNES, MD    +33145308235    stephane.vignes@cognacq-jay.fr   
Principal Investigator: STEPHANE VIGNES, MD         
Sub-Investigator: LAURA SIMON, MD         
Sponsors and Collaborators
CEN Biotech
medi
Investigators
Layout table for investigator information
Study Chair: MARLENE COUPE, MD University Hospital, Montpellier
Study Director: ERIC MARTIN, M. medi France
  Study Documents (Full-Text)

Documents provided by CEN Biotech:

Publications:
Leone N, Voirin N, Roche L, Binder-Foucard F, Woronoff AS, Delafosse P, Remontet L, Bossard N, Uhry Z. Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2015. Rapport technique. Saint-Maurice (Fra): Institut de veille sanitaire, 2015. 62 p
Grosclaude P, Remontet L, Belot A, Danzon A, Rasamimanana C, Bossard N. Survie des personnes atteintes de cancer en France, 1989-2007 - Etude à partir des registres des cancers du réseau Francim. Saint-Maurice: Institut de veille sanitaire; 2013. 412 p
Framework L. Best practice for the management of lymphoedema: an international consensus. London: MEP Ltd; 2006
Lymphoedema Framework International consensus. Best Practice for the management of Lymphoedema London: MEP Ltd, 2006 and 2nd Edition 2012

Layout table for additonal information
Responsible Party: CEN Biotech
ClinicalTrials.gov Identifier: NCT03492476     History of Changes
Other Study ID Numbers: C1512
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CEN Biotech:
Lymphedema of Upper Arm reduction
Lymphedema Upper Arm device

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases