At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓At least one open venous ulcer present for ≥4 weeks
- ✓Patient attending specialized vascular wound outpatient clinic at Nantes University Hospital
- ✓Informed consent provided
- ✕Under guardianship or legally incapacitated
- ✕Major cognitive disorders incompatible with protocol follow-up
- ✕Pregnant
- ✕Systolic Pressure Index <0.8 (indicates significant arterial disease)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Heel-free bandage for Venous Ulcer. Completed, enrolled 102 participants across 1 site.
Detailed 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 .
Study Details
Timeline
Interventions
The bandage is made by leaving the heel uncovered.