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Completed

NCT Number: NCT04046120

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

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 .

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Key information

Conditions

Venous Ulcer Behavior Cardiovascular Diseases Health Behavior Leg Ulcer Patient Acceptance of Health Care Patient Compliance Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Treatment Adherence and Compliance Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Nantes

Nantes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heel-free bandage

Other

The bandage is made by leaving the heel uncovered.

Primary outcomes

  1. Interface Pressure at V3

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

    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 outcomes

  1. Ankle Circumference

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

    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.

  2. Interface Pressure at V2

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

  3. Interface Pressure Between V2 and V3

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

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

  4. Patient Satisfaction: Questionnaire

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

  5. Number of Bandage Repairs

    Time frame: Day 0

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: COMPARACHILLE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2019
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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