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Foot and Ankle Post-operative Oedema Management Using Geko™

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ClinicalTrials.gov Identifier: NCT04927234
Recruitment Status : Not yet recruiting
First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Firstkind Ltd

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
Surgery Edema Device: geko™ therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Standard 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™
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Foot Health

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.



Primary Outcome Measures :
  1. 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

  2. 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.

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


Secondary Outcome Measures :
  1. Incidence of Adverse Events in each group [ Time Frame: From pre-surgery assessment until up to 90 days post-surgery ]
  2. 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)

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04927234


Contacts
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Contact: Kieron Day, DPhil +44 (0) 7921 106253 Kieron.Day@firstkindmedical.com
Contact: Marie-Therese Targett, PhD +44 (0) 7340903377 marie-therese.targett@firstkindmedical.com

Sponsors and Collaborators
Firstkind Ltd
Investigators
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Principal Investigator: Heath P Taylor, MB BS BSc(Hons) FRCS University Hospitals Dorset NHS Foundation Trust
Additional Information:
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Responsible Party: Firstkind Ltd
ClinicalTrials.gov Identifier: NCT04927234    
Other Study ID Numbers: FSK-F&A-001
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
geko
foot surgery
ankle surgery
oedema management
post-operative oedema
Additional relevant MeSH terms:
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Edema