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Foot and Ankle Post-operative Oedema Management Using Geko™

NCT04927234 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-02-10

No results posted yet for this study

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

Interventions

DEVICE

geko™ therapy

Neuro-muscular electrical stimulation of the peroneal nerve

Sponsors & Collaborators

  • Firstkind Ltd

    lead INDUSTRY

Principal Investigators

  • Shelain Patel, MB BS BSc(Hons) FRCS · Royal National Orthopaedic Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-07
Primary Completion
2024-07-09
Completion
2024-08-05
FDA Device
Yes

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04927234 on ClinicalTrials.gov