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Clinical Trial Summary

The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.


Clinical Trial Description

The geko™ device has a wide range of clinical applications including the post-operative management of oedema. Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during long term follow-up after surgery. This study is an open label, multi-centre prospective randomised study. The study patient population will be randomised on a 1:1 basis into two groups of 61 patients each. These groups are defined as Group A patients who receive geko™ therapy and SC i.e. the intervention group and Group B patients who receive Standard Care (SC) only i.e. no intervention. The participants will be assessed pre-surgery and up to 90 days post-surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04927234
Study type Interventional
Source Firstkind Ltd
Contact Kieron Day, DPhil
Phone +44 (0) 7921 106253
Email Kieron.Day@firstkindmedical.com
Status Recruiting
Phase N/A
Start date October 7, 2022
Completion date September 2024

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