Foot and Ankle Post-operative Oedema Management Using Geko™

August 18, 2023 updated by: Firstkind Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Rosa Busquets
        • Principal Investigator:
          • Andrea Sallent
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic Barcelona
        • Contact:
        • Principal Investigator:
          • Albert Baduell
  • United Kingdom
      • Stanmore, United Kingdom, HA7 4LP
        • Recruiting
        • The Royal National Orthopaedic Hospital NHS Trust
        • Contact:
        • Principal Investigator:
          • Shelain Patel
      • Tunbridge Wells, United Kingdom, TN2 4QJ
        • Recruiting
        • Maidstone and Tunbridge Wells NHS Trust
        • Contact:
        • Principal Investigator:
          • Justin Forder
  • United States
    • California
      • Capitola, California, United States, 95010
        • Recruiting
        • Golden State Orthopedics and Spine
        • Contact:
        • Principal Investigator:
          • Nicholas Abidi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Device: geko™ therapy
Neuro-muscular electrical stimulation of the peroneal nerve
Other Names:
  • NMES
  • geko
No Intervention: Standard of care
Patients will receive their standard of care as per hospital practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of post-operative oedema formation using the figure-of-eight tape measurement
Time Frame: From pre-surgery assessment until up to 90 days post-surgery
To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery. This will be done using the figure of eight tape measurement method
From pre-surgery assessment until up to 90 days post-surgery
Assessment of post-operative oedema formation using the pitting oedema scale
Time Frame: From pre-surgery assessment until up to 90 days post-surgery
To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery using the pitting oedema scale, where following a 2 second firm thumb press, 0 (min) indicates no oedema and 4 (max) is a very deep pit.
From pre-surgery assessment until up to 90 days post-surgery
Assessment of post-operative oedema formation using bioimpedance analysis (US sites only)
Time Frame: From pre-surgery assessment until up to 90 days post-surgery
To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery using a bioimpedance device to measure resistance to electrical current in both legs and calculating the percentage difference between the operated leg and the contralateral limb.
From pre-surgery assessment until up to 90 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events in each group
Time Frame: From pre-surgery assessment until up to 90 days post-surgery
From pre-surgery assessment until up to 90 days post-surgery
Incidence of device deficiencies
Time Frame: from start of geko treatment (immediately post-surgery) until up to 90 days post-surgery
To assess the number of geko device deficiencies (if any)
from start of geko treatment (immediately post-surgery) until up to 90 days post-surgery
Change in pain level using a visual analogue scale (VAS) score
Time Frame: From pre-surgery assessment until up to 90 days post-surgery
Assessing pain levels using a visual analogue scale (VAS) score, where 0 means no pain and 100 is the worst pain possible.
From pre-surgery assessment until up to 90 days post-surgery
Incidence of surgical wound healing
Time Frame: From surgery until up to 90 days post-surgery
Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe.
From surgery until up to 90 days post-surgery
Change in analgesia dosage
Time Frame: From pre-surgery assessment until up to 90 days post-surgery
Assessing changes in dosage of recorded analgesic medication taken by the patient
From pre-surgery assessment until up to 90 days post-surgery
Change in analgesia frequency
Time Frame: From pre-surgery assessment until up to 90 days post-surgery
Assessing changes of frequency of recorded analgesic medication taken by the patient
From pre-surgery assessment until up to 90 days post-surgery
Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ)
Time Frame: From pre-surgery assessment until up to 90 days post-surgery
Domains that are assessed in this questionnaire include walking/standing, pain and social interaction. Scores will range from 0 to 100, where 100 is most severe.
From pre-surgery assessment until up to 90 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firstkind Ltd

Investigators

  • Principal Investigator: Shelain Patel, MB BS BSc(Hons) FRCS, Royal National Orthopaedic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSK-F&A-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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