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

NCT ID: NCT04046120

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-11

Study Completion Date

2022-06-03

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 .

Detailed Description

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Conditions

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Venous Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Heel included

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Heel not included

he bandage is made by leaving the heel uncovered.

Group Type EXPERIMENTAL

Heel-free bandage

Intervention Type OTHER

The bandage is made by leaving the heel uncovered.

Interventions

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Heel-free bandage

The bandage is made by leaving the heel uncovered.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne POTTIER

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Chu de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC19_0072

Identifier Type: -

Identifier Source: org_study_id

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