The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

Conditions
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Edema, Kidney Transplant, Kidney Pancreas Transplant

Intervention / Treatment
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* Device: Geko device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Best Medical Therapy<br>Participants will follow standard post-transplant protocols with IPC | |
| Active Comparator: Geko device<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPC/TEDS, Geko device