SurgeryNCT04927234
Foot and Ankle Post-operative Oedema Management Using Geko™
A study testing geko™ therapy in people with Surgery and Edema, run by Firstkind Ltd at 5 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- geko™ therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 7 Oct 2022to 5 Aug 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain2 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clinic Barcelona
Barcelona, 08036
United Kingdom2 sites
Maidstone and Tunbridge Wells NHS Trust
Royal Tunbridge Wells, TN2 4QJ
The Royal National Orthopaedic Hospital NHS Trust
Stanmore, HA7 4LP
United States1 site
Golden State Orthopedics and Spine
Capitola, California, 95010
About this study
Official title: Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™
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.
Read the 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.
- Being tested
- geko™ therapy
- Keywords
- geko, foot surgery, ankle surgery, oedema management, post-operative oedema
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko™ therapyDevice
Also called geko, NMES
Neuro-muscular electrical stimulation of the peroneal nerve
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: geko™ therapy |
| Standard of care | No intervention | Patients will receive their standard of care as per hospital practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Day 14 post-op, Day 42 post-op, Day 90 post-op
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.
Measured: Baseline, Day 14 post-op, Day 42 post-op, Day 90 post-op
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.
Measured: Baseline, Day 14 post-op, Day 42 post-op, Day 90 post-op
Secondary outcomes (7)
Adverse Events
Incidence of Adverse Events in each group
Measured: From pre-surgery assessment until up to 90 days post-surgery
Device Deficiencies
To assess the number of geko device deficiencies (if any)
Measured: 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
Assessing pain levels using a visual analogue scale (VAS) score, where 0mm means no pain and 100mm is the worst pain possible.
Measured: Baseline, Day 14 post-op, Day 42 post-op, Day 90 post-op
Surgical Wound Healing
Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe.
Measured: From surgery until up to 90 days post-surgery
Change in Analgesia Dosage
Assessing changes in dosage of recorded analgesic medication taken by the patient
Measured: From pre-surgery assessment until up to 90 days post-surgery
Change in Analgesia Frequency
Analgesic medication use was recorded; however, participants were not asked to record the frequency of use. Therefore, frequency of analgesic use could not be analysed.
Measured: From pre-surgery assessment until up to 90 days post-surgery
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.
Measured: Baseline, Day 14 post-op, Day 42 post-op, Day 90 post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start7 Oct 2022
- Primary completion9 Jul 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Standard block randomisation
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shelain Patel, MB BS BSc(Hons) FRCS, Principal investigator, Royal National Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927234
- Sponsor's protocol ID
- FSK-F&A-001
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2021
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No