Foot and Ankle Post-operative Oedema Management Using Geko™

NCT04927234 | Completed FDA Device

• 1 other identifier: FSK-F&A-001
• Study Type: interventional
• Target: 123
• Locations: 3 countries
• Sites: 5

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.

Conditions

Surgery; Edema

Keywords

geko; foot surgery; ankle surgery; oedema management; post-operative oedema

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Incidence of Adverse Events in each group

  From pre-surgery assessment until up to 90 days post-surgery

• Incidence of device deficiencies

  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

  From pre-surgery assessment until up to 90 days post-surgery

• Incidence of surgical wound healing

  From surgery until up to 90 days post-surgery

• Change in analgesia dosage

  From pre-surgery assessment until up to 90 days post-surgery

Study Arms (2)

Standard of care + geko™ Therapy

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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

Interventions

geko™ therapy DEVICE

Neuro-muscular electrical stimulation of the peroneal nerve

Also known as: geko, NMES

Standard of care + geko™ Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (5)

Golden State Orthopedics and Spine

Capitola, California, 95010, United States

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Maidstone and Tunbridge Wells NHS Trust

Royal Tunbridge Wells, TN2 4QJ, United Kingdom

Location

The Royal National Orthopaedic Hospital NHS Trust

Stanmore, HA7 4LP, United Kingdom

Location

Related Links

• Device official website

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shelain Patel, MB BS BSc(Hons) FRCS

  Royal National Orthopaedic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Standard block randomisation

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 15, 2021
• Study Start: October 7, 2022
• Primary Completion: July 9, 2024
• Study Completion: August 5, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); US (1); GB (2)