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

KOB Medical Textiles Private Limited0 个研究点目标入组 34 人开始时间: 2026年7月30日最近更新: 2026年8月3日

试验速览

暂无简介。

•Age at least 18 years old - age of majority. This is the age at which a person gains the legal status of an adult.
•Subjects with chronic venous insufficiency of CEAP classification C4-C6R
•Medial malleolus ankle circumference - Position B - 18-32 cm
•Diagnosed CVI
•Indication for compression therapy of the lower leg ABPI 0.6-0.8
•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.
•Presence of written informed consent

•Significant physical limitations that may affect outcome
•Pregnancy, lactating mother - to be confirmed by answering the question on the case report form
•Concurrent participation in another clinical trial or study
•Persons committed to an institution by administrative or judicial order
•Persons dependent on the sponsor, investigator, or trial site

发起方

KOB Medical Textiles Private Limited