Foot and Ankle Post-operative Oedema Management Using Geko™

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2024-08-05

Brief Summary

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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.

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Detailed Description

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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

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Surgery Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Standard block randomisation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care + geko™ Therapy

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)

Group Type EXPERIMENTAL

geko™ therapy

Intervention Type DEVICE

Neuro-muscular electrical stimulation of the peroneal nerve

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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geko™ therapy

Neuro-muscular electrical stimulation of the peroneal nerve

Intervention Type DEVICE

Other Intervention Names

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geko NMES

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No