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Completed

NCT Number: NCT01860820

The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

geko device

Device

Primary outcomes

  1. Decrease in edema

    Time frame: Within 30 days post-transplant

    As measured by patient weight and leg diameter

Secondary outcomes

  1. Patient satisfaction

    Time frame: 3 and 6 days after transplant

    Patients will be asked to complete a questionnaire at these time points to assess their satisfaction

Other outcomes

  1. Use of diuretics

    Time frame: Within 30 days of transplant

    Diuretic use wil be tracked for participants in each of the arms to assess wither there is a difference.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 23, 2013
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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