N/A
N=102
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
Venous Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT04046120 ↗Enrolled (actual)
102
Serious AEs
—
Results posted
Mar 2026
Primary outcome: Primary: Interface Pressure at V3 — 28.4; 30.1 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heel-free bandage (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nantes University Hospital
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interface Pressure at V3 |
28.4; 30.1 | — |
| SECONDARY Ankle Circumference |
62.4; 58.9 | — |
| SECONDARY Interface Pressure at V2 |
36.4; 39.7 | — |
| SECONDARY Interface Pressure Between V2 and V3 |
-8; -9.7 | — |
| SECONDARY Patient Satisfaction: Questionnaire |
3; 20; 8; 6; 2; 9 | — |
| SECONDARY Number of Bandage Repairs |
37; 30; 5; 12; 1; 0 | — |
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 .
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04046120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.