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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04927234). StuddyBuddy aggregates publicly available trial information.