Venous Ulcer
Conditions
Keywords
varicose ulcer, compression bandages, patient compliance, heel, methods
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 .
Interventions
OTHERHeel-free bandage
The bandage is made by leaving the heel uncovered.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interface Pressure at V3 | 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
| Measure | Time frame | Description |
|---|---|---|
| Ankle Circumference | 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. |
| Interface Pressure at V2 | 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) |
| Interface Pressure Between V2 and V3 | 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. |
| Patient Satisfaction: Questionnaire | 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? |
| Number of Bandage Repairs | Day 0 | Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAnne POTTIER
Nantes University Hospital
Participant flow
Recruitment details
24 months of recruiting in hospital Each participant was followed between 4 to 6 weeks Recruitment began on the first inclusion : 10/11/2019 and the research ended with the last visite of the last patient on 06/03/2022. This study was designed as a monocentric, prospective, controlled, randomized in parallel groups, non-inferiority clinical trial.
Pre-assignment details
Eligible according to the inclusion and non-inclusion criteria
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 44 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 77.7 years STANDARD_DEVIATION 12.8 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment France | 102 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 1 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed