Foot and Ankle Post-operative Oedema Management Using Geko™

Sponsor
Firstkind Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04927234
Collaborator
(none)
122
2
2
24
61
2.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: geko™ therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Standard block randomisationStandard block randomisation
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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:
  • geko
  • NMES
  • No Intervention: Standard of care

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

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of post-operative oedema formation using the figure-of-eight tape measurement [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

    2. Assessment of post-operative oedema formation using the pitting oedema scale [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.

    3. Assessment of post-operative oedema formation using bioimpedance analysis [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.

    Secondary Outcome Measures

    1. Incidence of Adverse Events in each group [From pre-surgery assessment until up to 90 days post-surgery]

    2. Incidence of device deficiencies [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)

    3. Change in pain level using a visual analogue scale (VAS) score [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.

    4. Incidence of surgical wound healing [From surgery until up to 90 days post-surgery]

      Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe.

    5. Change in analgesia dosage [From pre-surgery assessment until up to 90 days post-surgery]

      Assessing changes in dosage of recorded analgesic medication taken by the patient

    6. Change in analgesia frequency [From pre-surgery assessment until up to 90 days post-surgery]

      Assessing changes of frequency of recorded analgesic medication taken by the patient

    7. Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Golden State Orthopedics and Spine Capitola California United States 95010
    2 The Royal National Orthopaedic Hospital NHS Trust Stanmore United Kingdom HA7 4LP

    Sponsors and Collaborators

    • Firstkind Ltd

    Investigators

    • Principal Investigator: Heath P Taylor, MB BS BSc(Hons) FRCS, University Hospitals Dorset NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Firstkind Ltd
    ClinicalTrials.gov Identifier:
    NCT04927234
    Other Study ID Numbers:
    • FSK-F&A-001
    First Posted:
    Jun 15, 2021
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Firstkind Ltd
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2022