The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

NCT01860820 | Completed

• 1 other identifier: 103618
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Kidney Pancreas Transplant; Edema

Keywords

IPC/TEDS; Geko device

Outcome Measures

Primary Outcomes (1)

• Decrease in edema

  As measured by patient weight and leg diameter

  Within 30 days post-transplant

Secondary Outcomes (1)

• Patient satisfaction

  3 and 6 days after transplant

Other Outcomes (1)

• Use of diuretics

  Within 30 days of transplant

Study Arms (2)

Best Medical Therapy

NO INTERVENTION

Participants will follow standard post-transplant protocols with IPC

Geko device

ACTIVE COMPARATOR

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

Interventions

Geko device DEVICE

Geko device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alp Sener, MD

  Lawson Health Research Institute, London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: June 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)