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The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

NCT ID: NCT01860820

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-12-31

Brief Summary

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This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Detailed Description

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This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standard of care IPC or TED stockings to help with circulation, the other group will use the geko device which is a newer device with Health Canada approval. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.

Conditions

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Kidney Transplant Kidney Pancreas Transplant Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Best Medical Therapy

Participants will follow standard post-transplant protocols with IPC

Group Type NO_INTERVENTION

No interventions assigned to this group

Geko device

Participants will be fitted with the device to ensure that it functions according to the manufacturer's instructions by a trained technician. This device will be changed every 24 hours. The device is worn on both legs and is worn for 24 hours a day. The device will first be put on the first day following the day of surgery and will then be changed the following day at the same time for a total of 7 days after surgery.

Group Type ACTIVE_COMPARATOR

Geko device

Intervention Type DEVICE

Interventions

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Geko device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female
* At least 18 years old
* Undergoing kidney or kidney pancreas transplant surgery as the recipient
* Able and willing to provide written informed consent
* Absence of known peripheral vascular disease
* Body Mass Index of between 18 and 34
* Leg circumference at site of geko™ device placement is 24" or less

Exclusion Criteria

* History of deep vein thrombosis
* Temporary or permanent cardiac pacing
* Patient is pregnant
* Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
* Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
* Previous leg(s) amputation
* Presence of any of the following in the site of intended device placement: cancerous lesion, swollen or infected or inflamed areas or skin eruptions i.e. phlebitis, thrombophlebitis, varicose veins
* History or signs of haematological disorders (especially in relation to clotting or coagulation disorders) including presence or history of thrombus formation
* BMI index \>36
* Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial
* History of implantable brain or other stimulator
* Patients who can not tolerate the stimulation from the GEKO device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alp Sener, MD

Role: PRINCIPAL_INVESTIGATOR

Lawson Health Research Institute, London Health Sciences Centre

Locations

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London Health Sciences Centre, University Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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103618

Identifier Type: -

Identifier Source: org_study_id