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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04927234
Other study ID # FSK-F&A-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 7, 2022
Est. completion date September 2024

Study information

Verified date August 2023
Source Firstkind Ltd
Contact Kieron Day, DPhil
Phone +44 (0) 7921 106253
Email Kieron.Day@firstkindmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 122
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
geko™ therapy
Neuro-muscular electrical stimulation of the peroneal nerve

Locations

Country Name City State
Spain Hospital Clinic Barcelona Barcelona
Spain Hospital Universitario Vall d'Hebron Barcelona
United Kingdom The Royal National Orthopaedic Hospital NHS Trust Stanmore
United Kingdom Maidstone and Tunbridge Wells NHS Trust Tunbridge Wells
United States Golden State Orthopedics and Spine Capitola California

Sponsors (1)

Lead Sponsor Collaborator
Firstkind Ltd

Countries where clinical trial is conducted

United States,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From pre-surgery assessment until up to 90 days post-surgery
Primary 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. From pre-surgery assessment until up to 90 days post-surgery
Primary 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. From pre-surgery assessment until up to 90 days post-surgery
Secondary Incidence of Adverse Events in each group From pre-surgery assessment until up to 90 days post-surgery
Secondary Incidence of device deficiencies 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
Secondary 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. From pre-surgery assessment until up to 90 days post-surgery
Secondary Incidence of surgical wound healing Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe. From surgery until up to 90 days post-surgery
Secondary Change in analgesia dosage Assessing changes in dosage of recorded analgesic medication taken by the patient From pre-surgery assessment until up to 90 days post-surgery
Secondary Change in analgesia frequency Assessing changes of frequency of recorded analgesic medication taken by the patient From pre-surgery assessment until up to 90 days post-surgery
Secondary 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. From pre-surgery assessment until up to 90 days post-surgery
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