Healthy Subjects
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEURGOBD001
Application with 50% overlapping
DEVICEURGOBD001 associated with wading
Application with 50% overlapping in association with wading
Sponsors
Laboratoires URGO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
3 separate sets : * URGOBD001 SSI compared with the SSI of a short stretch bandage * URGOBD001 SSI associated with wading bandage compared with the SSI of a short stretch bandage * URGOBD001 SSI compared with the SSI of a multi component bandage.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject with a body mass index of less than 30 (BMI = kg / m²), * Subject presenting a healthy skin on both legs without any sign of dermatological lesion, * Subject presenting a venous doppler of the lower limbs without detectable anomaly * Subject with a ankle brachial pressure index (ABPI) greater than 0.9 and less than 1.3 for each of the lower limbs, * Subject accepting to wear a compressive system on both legs for a period of three days.
Exclusion criteria
* Subject with chronic venous insufficiency whose stage is greater than or equal to 2 (CEAP classification of chronic venous diseases) * Subject with type I or II diabetes * Subject with lipoedema and / or dismorphic leg * Subject presenting ankle ankylosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSI(Static Stiffness Index) ≥ 10 mmHg | Hour 48 after the application | % of subject with a SSI≥ 10 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SSI (Static Stiffness Index) | From Hour 0 (Baseline) to Hour 72 (end of study) after application | Evolution over time |
| Interface pressure under the bandage | From Hour 0 (Baseline) to Hour 72 after application | Evolution over time |
| Slippage of the bandage in cm | From Hour 0 (Baseline) to Hour 72 (end of study) after application | 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) |
Countries
France
Contacts
Primary ContactBatot Géraldine, PhD
Outcome results
None listed