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Geko™ Therapy for Post-operative Swelling

N/A
Recruiting
Led By Shelain Patel, MB BS BSc(Hons) FRCS
Research Sponsored by Firstkind Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients that have been listed for forefoot and/or hindfoot surgery
Intact healthy skin at the site of geko™ device application
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from surgery until up to 90 days post-surgery
Awards & highlights

Study Summary

This trial will compare standard care to standard care plus geko™ therapy in order to assess oedema management and patient outcomes.

Who is the study for?
This trial is for adults over 18 who are scheduled for foot or ankle surgery and have healthy skin where the geko™ device will be placed. They must understand and agree to participate in the study, following all procedures, and provide written consent. People with lower limb trauma, those in other conflicting studies, pregnant individuals, or users of other neuro-modulation devices cannot join.Check my eligibility
What is being tested?
The trial is testing if adding geko™ therapy to standard post-surgery care helps manage swelling better than standard care alone after foot or ankle surgery. Participants are randomly chosen to receive either just standard care or both treatments for up to three months.See study design
What are the potential side effects?
Potential side effects from using the geko™ device may include discomfort at the application site or an adverse reaction if there's a failure in stimulating the common peroneal nerve as expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am listed for surgery on the front or back part of my foot.
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My skin is healthy where the geko™ device will be placed.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from surgery until up to 90 days post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from surgery until up to 90 days post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of post-operative oedema formation using bioimpedance analysis (US sites only)
Assessment of post-operative oedema formation using the figure-of-eight tape measurement
Assessment of post-operative oedema formation using the pitting oedema scale
Secondary outcome measures
Change in analgesia dosage
Change in analgesia frequency
Change in pain level using a visual analogue scale (VAS) score
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of care + geko™ TherapyExperimental Treatment1 Intervention
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)
Group II: Standard of careActive Control1 Intervention
Patients will receive their standard of care as per hospital practice.

Find a Location

Who is running the clinical trial?

Firstkind LtdLead Sponsor
24 Previous Clinical Trials
6,462 Total Patients Enrolled
Shelain Patel, MB BS BSc(Hons) FRCSPrincipal InvestigatorRoyal National Orthopaedic Hospital
Heath P Taylor, MB BS BSc(Hons) FRCSPrincipal InvestigatorUniversity Hospitals Dorset NHS Foundation Trust

Media Library

geko™ therapy Clinical Trial Eligibility Overview. Trial Name: NCT04927234 — N/A
Swelling Research Study Groups: Standard of care + geko™ Therapy, Standard of care
Swelling Clinical Trial 2023: geko™ therapy Highlights & Side Effects. Trial Name: NCT04927234 — N/A
geko™ therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04927234 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor currently have any open enrollment slots?

"As indicated by the clinicaltrials.gov, registration for this study has been suspended since August 4th 2022. Despite not recruiting any participants at present, there are still 346 other trials with open enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Foot and Ankle Post-operative Oedema Management Using Geko™
2022. "Foot and Ankle Post-operative Oedema Management Using Geko™". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04927234.
~22 spots leftby Sep 2024
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