Foot and Ankle Post-operative Oedema Management Using Geko™

Completed · Not applicable

Conditions studied: Surgery, Edema

In brief

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.

Key facts

Study ID

NCT04927234

Run by

Firstkind Ltd

People needed

123

Starts

2022-10-07

Expected to finish

2024-08-05

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 18 years
• Intact healthy skin at the site of geko™ device application.
• Patients that have been listed for forefoot and / or hindfoot surgery
• Patient understands and is willing to participate in the study and can comply with study procedures
• Patient is willing and able to give written informed consent

You may not qualify if…

• Pregnant
• Use of any other neuro-modulation device.
• Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
• No response to geko™ therapy i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
• Participation in any other clinical study that may interfere with the outcome of either study

Where it is running

• Golden State Orthopedics and Spine — Capitola, California, United States
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital Clinic Barcelona — Barcelona, Spain
• Maidstone and Tunbridge Wells NHS Trust — Royal Tunbridge Wells, United Kingdom
• The Royal National Orthopaedic Hospital NHS Trust — Stanmore, United Kingdom

Full record on ClinicalTrials.gov

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