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Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers (COMPARACHILLE)

Primary Purpose

Venous Ulcer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Heel-free bandage
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Ulcer focused on measuring varicose ulcer, compression bandages, patient compliance, heel, methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years old
  • Patient with at least one venous ulcer progressing for at least 4 weeks
  • Patient coming for a specialized outpatient consultation called "vascular wound" at Nantes University Hospital
  • Informed consent to participate in the study
  • Social security insurance affiliation

Exclusion Criteria:

  • Patients under guardianship
  • Patient with major cognitive disorders incompatible with follow-up of protocol
  • Pregnancy
  • Patient with an open leg ulcer with a Systolic Pressure Index < 0.8

Sites / Locations

  • Chu de Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Heel included

Heel not included

Arm Description

The bandage is made by including the heel as recommended in routine.

he bandage is made by leaving the heel uncovered.

Outcomes

Primary Outcome Measures

Interface pressure V3
Compare the interface pressure measurements generated by a medical compression bandage between two groups of patients with open venous ulcer(s) : experimental group: uncovered heel control group: heel covered by the bandage.

Secondary Outcome Measures

Ankle circumference
Compare the evolution or appearance of an edema in the ankle. The circumference of the ankle is measured with a tape measure using a technique called the figure of 8.
Interface pressure V2
Compare, between the two groups, the interface pressures measured during the installation of bandage at home by the home nurse (V2 follow-up visit), compared to the recommended pressures (30-40 mmHg)
Interface pressure V2 and V3
Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear.
Patient satisfaction: questionnaire
Between the two groups, compare patient satisfaction with a heterogeneous questionnaire. There is no scale or score. It is asked which type of bandage the patient prefers: with or without heel included?
Number of bandage repairs
Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure

Full Information

First Posted
August 2, 2019
Last Updated
July 13, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04046120
Brief Title
Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers
Acronym
COMPARACHILLE
Official Title
Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers: Non-inferiority, Controlled, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer
Keywords
varicose ulcer, compression bandages, patient compliance, heel, methods

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heel included
Arm Type
No Intervention
Arm Description
The bandage is made by including the heel as recommended in routine.
Arm Title
Heel not included
Arm Type
Experimental
Arm Description
he bandage is made by leaving the heel uncovered.
Intervention Type
Other
Intervention Name(s)
Heel-free bandage
Intervention Description
The bandage is made by leaving the heel uncovered.
Primary Outcome Measure Information:
Title
Interface pressure V3
Description
Compare the interface pressure measurements generated by a medical compression bandage between two groups of patients with open venous ulcer(s) : experimental group: uncovered heel control group: heel covered by the bandage.
Time Frame
48 hours after the bandage is applied (between week 4 and week 6)
Secondary Outcome Measure Information:
Title
Ankle circumference
Description
Compare the evolution or appearance of an edema in the ankle. The circumference of the ankle is measured with a tape measure using a technique called the figure of 8.
Time Frame
Day 0 and the last day (between week 4 and week 6)
Title
Interface pressure V2
Description
Compare, between the two groups, the interface pressures measured during the installation of bandage at home by the home nurse (V2 follow-up visit), compared to the recommended pressures (30-40 mmHg)
Time Frame
48 hours before the last visit of the protocol. (Between 4 and 6 weeks)
Title
Interface pressure V2 and V3
Description
Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear.
Time Frame
48 hours before the last visit of the protocol and at the last visit of the protocol (Between 4 and 6 weeks)
Title
Patient satisfaction: questionnaire
Description
Between the two groups, compare patient satisfaction with a heterogeneous questionnaire. There is no scale or score. It is asked which type of bandage the patient prefers: with or without heel included?
Time Frame
At the last visit of the protocol (Between 4 and 6 weeks)
Title
Number of bandage repairs
Description
Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years old Patient with at least one venous ulcer progressing for at least 4 weeks Patient coming for a specialized outpatient consultation called "vascular wound" at Nantes University Hospital Informed consent to participate in the study Social security insurance affiliation Exclusion Criteria: Patients under guardianship Patient with major cognitive disorders incompatible with follow-up of protocol Pregnancy Patient with an open leg ulcer with a Systolic Pressure Index < 0.8
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne POTTIER
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Nantes
City
Nantes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers

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