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

Nantes University Hospital102 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Venous Ulcer

Interventions

Heel-free bandage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Interface Pressure at 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.

Time frame: At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2)

Secondary Outcomes

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.

Time frame: Day 0 and the last day at V3 (between week 4 and week 8)

Interface Pressure at 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)

Time frame: 48 hours before the last visit of the protocol V3 (V3 which occurs between 4 to 8 weeks)

Interface Pressure Between V2 and V3

Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear.

Time frame: At V2 and at V3, 48 hours apart (V3 which occurs between 4 to 8 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?

Time frame: At the last visit of the protocol (Between 4 and 8 weeks)

Number of Bandage Repairs

Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure

Time frame: Day 0