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Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients

Primary Purpose

Venous Leg Ulcer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
geko plus R-2
Sponsored by
Firstkind Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Intact healthy skin at the site of device application
  3. Able to understand the Patient Information Sheet
  4. Willing and able to give informed consent
  5. Willing and able to follow the requirements of the protocol
  6. Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter,
  7. ABPI of 0.8-1.2 inclusive

Exclusion Criteria:

  1. Wound infection either acute or chronic
  2. History of significant haematological disorders or DVT with the preceding six months
  3. Pregnant
  4. Pacemakers or implantable defibrillators
  5. Use of any other neuro-modulation device
  6. Current use of TENS in pelvic region, back or legs
  7. Use of investigational drug or device within the past 4 weeks that may interfere with this study
  8. Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
  9. Recent trauma to the lower limbs
  10. Size of leg incompatible with the gekoTM plus R-2 device
  11. Obesity (BMI > 34)
  12. Any medication deemed to be significant by the Investigator
  13. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm.
  14. Diabetes
  15. Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    geko plus R-2

    Arm Description

    neuromuscular electrostimulation

    Outcomes

    Primary Outcome Measures

    The lower limb blood flow between gekoTM plus R-2 and IPC devices in VLU patients will be assessed.
    Duplex ultrasound of the femoral vein and artery will be performed with bilateral recording of blood flow velocity. After 10 minutes activation of either geko™ or IPC and after the 10 minutes the devices will swapped over and measurements performed. All measurements to be carried out in triplicate.

    Secondary Outcome Measures

    Adverse events assessments
    Patients will be monitored for adverse events throughout the duration of the study. Adverse events may be spontaneously reported by the subject, observed by the study personnel. Serious Adverse Events will be reported to the Sponsor, the National Research Ethics Service (NRES) recognised Research Ethics Committee.

    Full Information

    First Posted
    September 16, 2016
    Last Updated
    February 6, 2018
    Sponsor
    Firstkind Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02912858
    Brief Title
    Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients
    Official Title
    Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients: Comparison of Effects on Lower Limb Circulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study withdrawn
    Study Start Date
    September 2017 (Anticipated)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Firstkind Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic venous leg ulcers (VLU) are painful, debilitating wounds that place a significant burden on the patient, their family, and healthcare resources. Treating VLU can present a significant challenge to clinicians, who currently have a limited range of treatments at their disposal. The mainstay of treatment is compression bandaging, ambulation and elevation at rest. In addition to the aforementioned, intermittent pneumatic compression has also been utilised1. When applied to the leg or foot intermittent pneumatic compression (IPC) devices intermittently inflate and deflate to increase venous return. These devices can be uncomfortable to wear, and compliance can be inhibited because of size, weight and external power source that limit the patient's mobility. In patients who cannot walk, or in those who are unable to tolerate compression bandaging, ulcers may deteriorate and never heal. Accordingly, there is a need for novel, alternative devices or strategies that can be used to complement or replace compression bandage therapy.
    Detailed Description
    This is a single-centre randomised intra-patient comparison of gekoTM plus R-2 R-2 and IPC. Blood flow will be measured after each device has been activated for 10 minutes with a 10 minute rest between devices to allow blood flow to return to baseline. The order the devices will be fitted is determined randomly. Activation of the device for 10 minutes before measurement is deemed appropriate as previous studies have demonstrated significant increases in blood flow following as little as five minutes use of the devices. In this short study the standard of care (typically compression bandaging), will be suspended temporarily to allow the fitting of the gekoTM plus R-2 and IPC devices in order to measure blood flow. This is not seen as a risk to the patient as the device is only in operation for 30 minutes plus 10 minutes rest within the care pathway.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Leg Ulcer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    geko plus R-2
    Arm Type
    Experimental
    Arm Description
    neuromuscular electrostimulation
    Intervention Type
    Device
    Intervention Name(s)
    geko plus R-2
    Intervention Description
    The gekoTM plus R-2 devices (acting on the common peroneal nerve) and IPC devices will be activated for 10mins prior to measuring blood flow. The sequence of application of IPC and gekoTM plus R-2 devices will be randomly selected with 10 minutes recovery between active therapies.
    Primary Outcome Measure Information:
    Title
    The lower limb blood flow between gekoTM plus R-2 and IPC devices in VLU patients will be assessed.
    Description
    Duplex ultrasound of the femoral vein and artery will be performed with bilateral recording of blood flow velocity. After 10 minutes activation of either geko™ or IPC and after the 10 minutes the devices will swapped over and measurements performed. All measurements to be carried out in triplicate.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Adverse events assessments
    Description
    Patients will be monitored for adverse events throughout the duration of the study. Adverse events may be spontaneously reported by the subject, observed by the study personnel. Serious Adverse Events will be reported to the Sponsor, the National Research Ethics Service (NRES) recognised Research Ethics Committee.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years Intact healthy skin at the site of device application Able to understand the Patient Information Sheet Willing and able to give informed consent Willing and able to follow the requirements of the protocol Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter, ABPI of 0.8-1.2 inclusive Exclusion Criteria: Wound infection either acute or chronic History of significant haematological disorders or DVT with the preceding six months Pregnant Pacemakers or implantable defibrillators Use of any other neuro-modulation device Current use of TENS in pelvic region, back or legs Use of investigational drug or device within the past 4 weeks that may interfere with this study Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator. Recent trauma to the lower limbs Size of leg incompatible with the gekoTM plus R-2 device Obesity (BMI > 34) Any medication deemed to be significant by the Investigator Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm. Diabetes Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients

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