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)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Venous Ulcer

Treatments: Other: Heel-free bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT04046120

RC19_0072

Details and patient eligibility

About

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 .

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Heel included

No Intervention group

Description:

The bandage is made by including the heel as recommended in routine.

Heel not included

Experimental group

Description:

he bandage is made by leaving the heel uncovered.

Treatment:

Other: Heel-free bandage