Foot and Ankle Post-operative Oedema Management Using Geko™
Primary Purpose
Surgery, Edema
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
geko™ therapy
Sponsored by
About this trial
This is an interventional treatment trial for Surgery focused on measuring geko, foot surgery, ankle surgery, oedema management, post-operative oedema
Eligibility 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
Sites / Locations
- Golden State Orthopedics and SpineRecruiting
- Hospital Universitario Vall d'HebronRecruiting
- Hospital Clinic BarcelonaRecruiting
- The Royal National Orthopaedic Hospital NHS TrustRecruiting
- Maidstone and Tunbridge Wells NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Standard of care + geko™ Therapy
Standard of care
Arm 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)
Patients will receive their standard of care as per hospital practice.
Outcomes
Primary Outcome Measures
Assessment of post-operative oedema formation using the figure-of-eight tape measurement
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
Assessment of post-operative oedema formation using the pitting oedema scale
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.
Assessment of post-operative oedema formation using bioimpedance analysis (US sites only)
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
Incidence of Adverse Events in each group
Incidence of device deficiencies
To assess the number of geko device deficiencies (if any)
Change in pain level using a visual analogue scale (VAS) score
Assessing pain levels using a visual analogue scale (VAS) score, where 0 means no pain and 100 is the worst pain possible.
Incidence of surgical wound healing
Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe.
Change in analgesia dosage
Assessing changes in dosage of recorded analgesic medication taken by the patient
Change in analgesia frequency
Assessing changes of frequency of recorded analgesic medication taken by the patient
Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04927234
Brief Title
Foot and Ankle Post-operative Oedema Management Using Geko™
Official Title
Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Firstkind Ltd
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Edema
Keywords
geko, foot surgery, ankle surgery, oedema management, post-operative oedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Standard block randomisation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care + geko™ Therapy
Arm Type
Experimental
Arm 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)
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Patients will receive their standard of care as per hospital practice.
Intervention Type
Device
Intervention Name(s)
geko™ therapy
Other Intervention Name(s)
geko, NMES
Intervention Description
Neuro-muscular electrical stimulation of the peroneal nerve
Primary Outcome Measure Information:
Title
Assessment of post-operative oedema formation using the figure-of-eight tape measurement
Description
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
Time Frame
From pre-surgery assessment until up to 90 days post-surgery
Title
Assessment of post-operative oedema formation using the pitting oedema scale
Description
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.
Time Frame
From pre-surgery assessment until up to 90 days post-surgery
Title
Assessment of post-operative oedema formation using bioimpedance analysis (US sites only)
Description
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.
Time Frame
From pre-surgery assessment until up to 90 days post-surgery
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events in each group
Time Frame
From pre-surgery assessment until up to 90 days post-surgery
Title
Incidence of device deficiencies
Description
To assess the number of geko device deficiencies (if any)
Time Frame
from start of geko treatment (immediately post-surgery) until up to 90 days post-surgery
Title
Change in pain level using a visual analogue scale (VAS) score
Description
Assessing pain levels using a visual analogue scale (VAS) score, where 0 means no pain and 100 is the worst pain possible.
Time Frame
From pre-surgery assessment until up to 90 days post-surgery
Title
Incidence of surgical wound healing
Description
Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe.
Time Frame
From surgery until up to 90 days post-surgery
Title
Change in analgesia dosage
Description
Assessing changes in dosage of recorded analgesic medication taken by the patient
Time Frame
From pre-surgery assessment until up to 90 days post-surgery
Title
Change in analgesia frequency
Description
Assessing changes of frequency of recorded analgesic medication taken by the patient
Time Frame
From pre-surgery assessment until up to 90 days post-surgery
Title
Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ)
Description
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.
Time Frame
From pre-surgery assessment until up to 90 days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kieron Day, DPhil
Phone
+44 (0) 7921 106253
Email
Kieron.Day@firstkindmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Therese Targett, PhD
Phone
+44 (0) 7340903377
Email
marie-therese.targett@firstkindmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelain Patel, MB BS BSc(Hons) FRCS
Organizational Affiliation
Royal National Orthopaedic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Golden State Orthopedics and Spine
City
Capitola
State/Province
California
ZIP/Postal Code
95010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rich Anderson
Email
randerson@orthonorcal.com
First Name & Middle Initial & Last Name & Degree
Nicholas Abidi
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Altayo
Email
altayo.marta@gmail.com
First Name & Middle Initial & Last Name & Degree
Rosa Busquets
First Name & Middle Initial & Last Name & Degree
Andrea Sallent
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Montsant Jornet
Email
JORNET@clinic.cat
First Name & Middle Initial & Last Name & Degree
Albert Baduell
Facility Name
The Royal National Orthopaedic Hospital NHS Trust
City
Stanmore
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nana Okine
Email
nana.okine@nhs.net
First Name & Middle Initial & Last Name & Degree
Shelain Patel
Facility Name
Maidstone and Tunbridge Wells NHS Trust
City
Tunbridge Wells
ZIP/Postal Code
TN2 4QJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Joy
Email
b.joy@nhs.net
First Name & Middle Initial & Last Name & Degree
Justin Forder
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.gekodevices.com/en-uk/
Description
Device official website
Learn more about this trial
Foot and Ankle Post-operative Oedema Management Using Geko™
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