The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

Kidney Transplant Clinical Trial

Official title:

The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860820
• Other study ID #: 103618
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2019

Study information

• Verified date: October 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Kidney Pancreas Transplant
• Kidney Transplant

Intervention

Device:
• Geko device

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Decrease in edema	As measured by patient weight and leg diameter	Within 30 days post-transplant
Secondary	Patient satisfaction	Patients will be asked to complete a questionnaire at these time points to assess their satisfaction	3 and 6 days after transplant