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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heel-free bandage | Other | The bandage is made by leaving the heel uncovered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) :
| At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2) |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Circumference | 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. | Day 0 and the last day at V3 (between week 4 and week 8) |
| Interface Pressure at V2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne POTTIER | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Nantes | Nantes | France |
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Eligible according to the inclusion and non-inclusion criteria
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Heel Included | The bandage is made by including the heel as recommended in routine. |
| FG001 | Heel Not Included | he bandage is made by leaving the heel uncovered. Heel-free bandage: The bandage is made by leaving the heel uncovered. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2021 |
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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) |
| 48 hours before the last visit of the protocol V3 (V3 which occurs between 4 to 8 weeks) |
| Interface Pressure Between V2 and V3 | Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear. | At V2 and at V3, 48 hours apart (V3 which occurs between 4 to 8 weeks) |
| Patient Satisfaction: Questionnaire | 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? | At the last visit of the protocol (Between 4 and 8 weeks) |
| Number of Bandage Repairs | Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure | Day 0 |
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| NOT COMPLETED |
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The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below:
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| ID | Title | Description |
|---|---|---|
| BG000 | Heel Included | The bandage is made by including the heel as recommended in routine. |
| BG001 | Heel Not Included | he bandage is made by leaving the heel uncovered. Heel-free bandage: The bandage is made by leaving the heel uncovered. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below:
| Count of Participants | Participants |
| |||||||||||||||
| Age, Continuous | The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: Wounds healed before the end of follow-up: 5 patients Postponed visit - COVID: 3 patients Discontinuation of the study due to inability to tolerate the bandage: 3 patients Change of arm after randomization: 2 patients Refusal by the nursing home to carry out the protocol: 1 patient Patient hospitalized: 1 patient Death: 1 patient Bandage redone between V2 and V3: 1 patient | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | The per-protocol population included 85 patients. Reasons for exclusion of the 17 patients below: Wounds healed before the end of follow-up: 5 patients Postponed visit - COVID: 3 patients Discontinuation of the study due to inability to tolerate the bandage: 3 patients Change of arm after randomization: 2 patients Refusal by the nursing home to carry out the protocol: 1 patient Patient hospitalized: 1 patient Death: 1 patient Bandage redone between V2 and V3: 1 patient | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Ankle Circumference | 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. | Posted | Mean | 95% Confidence Interval | cm | Day 0 and the last day at V3 (between week 4 and week 8) |
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| Secondary | Interface Pressure at V2 | 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) | Posted | Mean | 95% Confidence Interval | mmHg | 48 hours before the last visit of the protocol V3 (V3 which occurs between 4 to 8 weeks) |
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| Secondary | Interface Pressure Between V2 and V3 | Compare, between the two groups, the evolution of interface pressures after 48 hours of bandage wear. | Posted | Mean | 95% Confidence Interval | mmHg | At V2 and at V3, 48 hours apart (V3 which occurs between 4 to 8 weeks) |
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| Secondary | Patient Satisfaction: Questionnaire | 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? | Posted | Count of Participants | Participants | At the last visit of the protocol (Between 4 and 8 weeks) |
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| Secondary | Number of Bandage Repairs | Evaluate the number of bandage repairs required to reach the recommended therapeutic pressure | Posted | Count of Participants | Participants | Day 0 |
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| Primary | 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) :
| Posted | Mean | 95% Confidence Interval | mmHg | At V3 (i.e. between 4 to 8 weeks): 48h after the final bandagin (which occurs at V2) |
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No adverse event collected due to the typology of the study: interventional research involving risk and minimal constraints (RIPH2)
No adverse event collected due to the typology of the study: interventional research involving risk and minimal constraints (RIPH2) The vigilance applied was the vigilance of care, as for any clinical trial RIPH2 but not a vigilance that depended on the Sponsor
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heel Included | The bandage is made by including the heel as recommended in routine. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Heel Not Included | he bandage is made by leaving the heel uncovered. Heel-free bandage: The bandage is made by leaving the heel uncovered. | 1 | 1 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madam Anne MAUVILAIN-POTTIER | CHU of Nantes - Mobile vascular wound care unit | 0240083473 | +33 | anne.mauvilain@chu-nantes.fr |
| Feb 9, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Between 18 and 65 years |
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| >=65 years |
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