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

NCT04046120 | Completed Results

• 1 other identifier: RC19_0072
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Venous Ulcer

Keywords

varicose ulcer; compression bandages; patient compliance; heel; methods

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• Ankle Circumference

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

• Interface Pressure at V2

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

• Interface Pressure Between V2 and V3

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

• Patient Satisfaction: Questionnaire

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

• Number of Bandage Repairs

  Day 0

Study Arms (2)

Heel included

NO INTERVENTION

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

Heel not included

EXPERIMENTAL

he bandage is made by leaving the heel uncovered.

Other: Heel-free bandage

Interventions

Heel-free bandage OTHER

The bandage is made by leaving the heel uncovered.

Heel not included

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Chu de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Varicose Ulcer; Patient Compliance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Madam Anne MAUVILAIN-POTTIER
• Organization: CHU of Nantes - Mobile vascular wound care unit

anne.mauvilain@chu-nantes.fr

0240083473

Study Officials

• Anne POTTIER

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: October 11, 2019
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)