The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

Not Applicable

Completed

• Conditions: Kidney Transplant; Kidney Pancreas Transplant; Edema
• Interventions: Device: Geko device

• Registration Number: NCT01860820
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-23
• Study Start: 2015-06
• Primary Completion: 2019-09
• Study Completion: 2019-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geko device	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.

Primary Outcome Measures

Name	Time	Method
Decrease in edema	Within 30 days post-transplant	As measured by patient weight and leg diameter

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	3 and 6 days after transplant	Patients will be asked to complete a questionnaire at these time points to assess their satisfaction

Trial Locations

Locations (1)

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada