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

Not Applicable

Completed

• Conditions: Venous Ulcer
• Interventions: Other: Heel-free bandage

• Registration Number: NCT04046120
• Lead Sponsor: Nantes University Hospital

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Study Start: 2019-10-11
• Primary Completion: 2022-06-03
• Study Completion: 2022-06-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heel not included	Heel-free bandage	he bandage is made by leaving the heel uncovered.

Primary Outcome Measures

Name	Time	Method
Interface pressure V3	48 hours after the bandage is applied (between week 4 and week 6)	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

Name	Time	Method
Ankle circumference	Day 0 and the last day (between week 4 and week 6)	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.
Patient satisfaction: questionnaire	At the last visit of the protocol (Between 4 and 6 weeks)	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	Day 0	Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure
Interface pressure V2 and V3	48 hours before the last visit of the protocol and at the last visit of the protocol (Between 4 and 6 weeks)	Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear.
Interface pressure V2	48 hours before the last visit of the protocol. (Between 4 and 6 weeks)	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)

Trial Locations

Locations (1)

Chu de Nantes; 🇫🇷 Nantes, France