Foot and Ankle Post-operative Oedema Management Using Geko™

Firstkind

Status: Completed

Conditions: Edema; Surgery

Treatments: Device: geko™ therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04927234

FSK-F&A-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

123 participants in 2 patient groups

Standard of care + geko™ Therapy

Experimental group

Description:

In addition to their standard of care, for patients randomised to the intervention arm, geko™ therapy will be applied immediately post-surgery on the operated leg and administered for 24 hours / day whilst the patient remains in hospital, after which geko™ therapy will then be applied for 12hrs / day until the patient returns for their first post-operative follow-up visit (Day 14 ± 2 days post-surgery)

Treatment:

Device: geko™ therapy

Standard of care

No Intervention group

Description:

Patients will receive their standard of care as per hospital practice.