NCT04927234

Foot and Ankle Post-operative Oedema Management Using Geko™

Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Firstkind Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Surgery
• Edema

Interventions

Type	Name	Description
DEVICE	geko™ therapy	Neuro-muscular electrical stimulation of the peroneal nerve

Timeline

• Start date: 2022-10-07
• Primary completion: 2024-07-09
• Completion: 2024-08-05
• First posted: 2021-06-15
• Last updated: 2025-02-10

Locations

5 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated device study