Health Condition 1: I872- Venous insufficiency (chronic) (peripheral)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at least 18 years old - age of majority. This is the age at which a person gains the legal status of an adult. 2. Subjects with chronic venous insufficiency of CEAP classification C4-C6R 3. Medial malleolus ankle circumference - Position B - 18-32 cm 4. Diagnosed CVI 5. Indication for compression therapy of the lower leg ABPI 0.6-0.8 6. Area of skin on which the pressure measurement transducer - Pico Press- is to be placed must be free of wounds or other signs of damage. 7. Presence of written informed consent
Exclusion criteria
Exclusion criteria: 1. Significant physical limitations that may affect outcome 2. Pregnancy, lactating mother - to be confirmed by answering the question on the case report form 3. Concurrent participation in another clinical trial or study 4. Persons committed to an institution by administrative or judicial order 5. Persons dependent on the sponsor, investigator, or trial site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sub bandage interface pressureTimepoint: Day 1, Day 3, Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bandage Adaptation to Limb Morphology 2. Bandage Slippage 3. Static Stiffness IndexTimepoint: Day 1, Day 3, Day 7 | — |
Countries
India
Contacts
Sree Parthas Multispeciality Hospital