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Compression bandage for legs to increase poor blood circulation in patients

Open Label, Prospective, Non-invasive, Non-Randomized, Non-Comparative, Single Arm Interventional Clinical Investigation of 2-in-1 Compression Bandage with Reduced Pressure for treatment of chronic venous insufficiency - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113766
Enrollment
34
Registered
2026-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I872- Venous insufficiency (chronic) (peripheral)

Interventions

Intervention1: VisioCompress 1 Lite: Patients diagnosed with CVI will be bandaged using the compression bandage 2-in-1 Compression Bandage with Reduced Pressure and monitored for 7 days. Control Inter

Sponsors

KOB Medical Textiles Private Limited
Lead Sponsor

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

MeasureTime frame
Sub bandage interface pressureTimepoint: Day 1, Day 3, Day 7

Secondary

MeasureTime frame
1. Bandage Adaptation to Limb Morphology 2. Bandage Slippage 3. Static Stiffness IndexTimepoint: Day 1, Day 3, Day 7

Countries

India

Contacts

Public ContactDr T Rathnaganpathi

Sree Parthas Multispeciality Hospital

dr.rathnaganpathithulasikumar@gmail.com8939005968

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026