Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.
Compression therapy is widely used in the treatment of chronic venous leg ulcers (VLUs). The clinical performance of a compression system depends on the apply pressure and the stiffness.
The static stiffness index (SSI) is defined by the difference in interface pressure measured when the subject is standing (working pressure) and the interface pressure measured when the subject is in the lying position (resting pressure).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short stretch bandage | Active Comparator | Application with 50% overlap in combinaison with wading |
|
| Multi componant bandage | Active Comparator | Application with 50% overlap |
|
| Short stretch bandage bis | Active Comparator | Application with 50% overlap in combinaison with wading |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| URGOBD001 | Device | Application with 50% overlapping |
|
| Measure | Description | Time Frame |
|---|---|---|
| SSI(Static Stiffness Index) ≥ 10 mmHg | % of subject with a SSI≥ 10 mmHg | Hour 48 after the application |
| Measure | Description | Time Frame |
|---|---|---|
| SSI (Static Stiffness Index) | Evolution over time | From Hour 0 (Baseline) to Hour 72 (end of study) after application |
| Interface pressure under the bandage | Evolution over time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Batot Géraldine, PhD | Contact | +33 3 80 44 28 46 | g.batot@fr.urgo.com |
| Name | Affiliation | Role |
|---|---|---|
| Benigni JP, MD | Intertek France clinical studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intertek France Clinical studies | Recruiting | Paris | 75013 | France |
Not provided
3 separate sets :
Not provided
Not provided
Not provided
Not provided
| URGOBD001 associated with wading | Device | Application with 50% overlapping in association with wading |
|
| From Hour 0 (Baseline) to Hour 72 after application |
| Slippage of the bandage in cm | Assessed by measuring with a tape at each time (i) the length (L) from the top of the bandage to the floor, Slippage (cm) = L(Time 0) - L (Time i) | From Hour 0 (Baseline) to Hour 72 (end of study) after application |