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The multicentre randomised gekoâ„¢ 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 gekoâ„¢ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.
The gekoâ„¢ 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 gekoâ„¢ 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 gekoâ„¢ 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Standard of care | No Intervention | Patients will receive their standard of care as per hospital practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gekoâ„¢ therapy | Device | Neuro-muscular electrical stimulation of the peroneal nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of post-operative oedema formation using the figure-of-eight tape measurement | To assess the effect of gekoâ„¢ 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 gekoâ„¢ 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 gekoâ„¢ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events in each group | From pre-surgery assessment until up to 90 days post-surgery | |
| Incidence of device deficiencies | To assess the number of geko device deficiencies (if any) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shelain Patel, MB BS BSc(Hons) FRCS | Royal National Orthopaedic Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden State Orthopedics and Spine | Capitola | California | 95010 | United States | ||
| Hospital Universitario Vall d'Hebron |
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| Label | URL |
|---|---|
| Device official website | View source |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 28, 2026 | Feb 13, 2026 | 4 | ||
| Mar 5, 2026 |
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Standard block randomisation
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| 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 0 means no pain and 100 is the worst pain possible. | From pre-surgery assessment until up to 90 days post-surgery |
| 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 |
| 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 |
| 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 |
| 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 |
| Barcelona |
| 08035 |
| Spain |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Maidstone and Tunbridge Wells NHS Trust | Royal Tunbridge Wells | TN2 4QJ | United Kingdom |
| The Royal National Orthopaedic Hospital NHS Trust | Stanmore | HA7 4LP | United Kingdom |
| Mar 25, 2026 |
| 5 |