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)

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

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 .

Study Overview

• Status: Completed
• Conditions: Venous Ulcer
• Intervention / Treatment: Other: Heel-free bandage

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Heel included; The bandage is made by including the heel as recommended in routine.
Experimental: Heel not included; he bandage is made by leaving the heel uncovered.	Other: Heel-free bandage; The bandage is made by leaving the heel uncovered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours after the bandage is applied (between week 4 and week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 and the last day (between week 4 and week 6)
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)	48 hours before the last visit of the protocol. (Between 4 and 6 weeks)
Interface pressure V2 and V3	Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear.	48 hours before the last visit of the protocol and at the last visit of the protocol (Between 4 and 6 weeks)
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?	At the last visit of the protocol (Between 4 and 6 weeks)
Number of bandage repairs	Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure	Day 0

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Anne POTTIER, CHU Nantes

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): June 3, 2022
• Study Completion (Actual): June 3, 2022

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: methods; compression bandages; patient compliance; varicose ulcer; heel
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer
• Other Study ID Numbers: RC19_0072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No