Back to resultsThe Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
Primary Purpose
Kidney Transplant, Kidney Pancreas Transplant, Edema
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Geko device
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplant focused on measuring IPC/TEDS, Geko device
Eligibility Criteria
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
Sites / Locations
- London Health Sciences Centre, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Best Medical Therapy
Geko device
Arm Description
Participants will follow standard post-transplant protocols with IPC
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.
Outcomes
Primary Outcome Measures
Decrease in edema
As measured by patient weight and leg diameter
Secondary Outcome Measures
Patient satisfaction
Patients will be asked to complete a questionnaire at these time points to assess their satisfaction
Full Information
NCT ID
NCT01860820
First Posted
May 21, 2013
Last Updated
October 15, 2021
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01860820
Brief Title
The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
Official Title
The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant, Kidney Pancreas Transplant, Edema
Keywords
IPC/TEDS, Geko device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Best Medical Therapy
Arm Type
No Intervention
Arm Description
Participants will follow standard post-transplant protocols with IPC
Arm Title
Geko device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Geko device
Primary Outcome Measure Information:
Title
Decrease in edema
Description
As measured by patient weight and leg diameter
Time Frame
Within 30 days post-transplant
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patients will be asked to complete a questionnaire at these time points to assess their satisfaction
Time Frame
3 and 6 days after transplant
Other Pre-specified Outcome Measures:
Title
Use of diuretics
Description
Diuretic use wil be tracked for participants in each of the arms to assess wither there is a difference.
Time Frame
Within 30 days of transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Sener, MD
Organizational Affiliation
Lawson Health Research Institute, London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
We'll reach out to this number within 24 hrs