The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

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.

Study Overview

• Status: Completed
• Conditions: Edema; Kidney Transplant; Kidney Pancreas Transplant
• Intervention / Treatment: Device: Geko device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Best Medical Therapy; Participants will follow standard post-transplant protocols with IPC
Active Comparator: 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.	Device: Geko device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in edema	As measured by patient weight and leg diameter	Within 30 days post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patients will be asked to complete a questionnaire at these time points to assess their satisfaction	3 and 6 days after transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of diuretics	Diuretic use wil be tracked for participants in each of the arms to assess wither there is a difference.	Within 30 days of transplant

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Alp Sener, MD, Lawson Health Research Institute, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: IPC/TEDS; Geko device
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: 103618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No