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

Study Overview
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Brief Summary
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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 .

Official Title
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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: Non-inferiority, Controlled, Randomized Trial

Conditions
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Venous Ulcer

Intervention / Treatment
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* Other: Heel-free bandage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicose ulcer, compression bandages, patient compliance, heel, methods