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Completed
NCT04927234
Foot and Ankle Post-operative Oedema Management Using Geko™
Conditions: Surgery, Edema
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 123
Sponsor: Firstkind Ltd
Location: Golden State Orthopedics and Spine Capitola California
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.
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
Source: ClinicalTrials.gov (NCT04927234). StuddyBuddy aggregates publicly available trial information.