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

Venous Ulcer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046120
• Other study ID #: RC19_0072
• Status: Completed
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: June 3, 2022

Study information

• Verified date: July 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Other:
• Heel-free bandage
The bandage is made by leaving the heel uncovered.

Locations

Country	Name	City	State
France	Chu de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of bandage repairs	Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure	Day 0