Peripheral Vascular Disease and Nerve Stimulation (CCLINS)

This study is currently recruiting participants.
Verified September 2013 by University of Hull
Sponsor:
Information provided by (Responsible Party):
Daniel Carradice, University of Hull
ClinicalTrials.gov Identifier:
NCT01942941
First received: September 4, 2013
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

A study to see what effect the geko™ device has on blood flow in patients with lower limb vascular disease.


Condition Intervention Phase
Critical Limb Ischaemia
Claudication
Ulcers
Varicose Veins
Post Angioplasty
Device: geko™ electrical stimulation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Observational Series to Establish the Haemodynamic Efficacy and Tolerability of gekoTM Device in Patients With Lower Limb Vascular Disease

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • Effect of geko™ on blood volume flow through the femoral artery [ Time Frame: Study day i.e. 1 day ] [ Designated as safety issue: No ]
    Measured with ultrasound doppler


Secondary Outcome Measures:
  • Effect of geko™ on venous blow flow [ Time Frame: Study day i.e. 1 day ] [ Designated as safety issue: No ]
    Measured with ultrasound doppler

  • Effect of geko™ on microcirculatory flow [ Time Frame: Study day i.e. 1 day ] [ Designated as safety issue: No ]
    Measured with laser doppler

  • Establish whether effects of geko™ are local or systemic [ Time Frame: Study day i.e. 1 day ] [ Designated as safety issue: No ]
    Measurements will be taken from both the leg on which the device is active and the leg with no geko™

  • Effect of geko™ on patients symptoms [ Time Frame: study day i.e. 1 day ] [ Designated as safety issue: No ]
    Completion of McGill pain questionnaire and visual analogue scale

  • Acceptability and tolerability of geko™ device [ Time Frame: study day i.e. 1 day ] [ Designated as safety issue: No ]
    Completion of tolerability questionnaire

  • Effect of gekoTM on calf circumference [ Time Frame: Study day i.e. 1 day ] [ Designated as safety issue: No ]
    Calf circumference measured before and after device


Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: geko™ electrical stimulation
Applied to stimulate peroneal nerve unilaterally
Device: geko™ electrical stimulation
applied to stimulate peroneal nerve and cause active muscle twitch

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >18 years
  • Absence of haematological disorders or DVT (deep vein thrombosis) in the preceding 12 months
  • Intact cutaneous sensations to nocioception in the lower limb, as determined by the investigator
  • Intact healthy skin at site of application
  • On effective contraception if sexually active - oral contraceptive pill (> 3 months use), condoms, intrauterine contraceptive device, depot injection
  • Able to understand the Patient Information Sheet and capable and willing to give informed consent and follow the protocol requirements

Exclusion Criteria:

  • History of haematological disorder or DVT in the preceding 12 months
  • Pregnant or planning to become pregnant during study duration
  • Pacemakers or implantable defibrillators
  • Use of any other neuro-modulation device
  • Current use of TENS (transcutaneous electrical nerve stimulation) in pelvic region, back or legs
  • Use of investigational drug/device therapy within past 4 weeks that may interfere with this study.
  • Significant varicose veins or lower limb ulceration.
  • Recent surgery (such as abdominal, gynaecological, hip knee replacement).
  • Recent trauma to lower limbs.
  • Chronic Obesity (BMI Index >34).
  • Any medication judged to be significant by the Principal Investigator.
  • Any significant illness during the four (4) weeks preceding the screening period of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942941

Contacts
Contact: Rachel Barnes, MRCS, MA 01482674643 rachel.barnes@hey.nhs.uk

Locations
United Kingdom
Hull Royal Infirmary Recruiting
Hull, EastRiding of Yorkshire, United Kingdom, HU3 2JZ
Contact: Rachel Barnes         
Principal Investigator: Rachel Barnes, MRCS, MA         
Sponsors and Collaborators
University of Hull
Investigators
Principal Investigator: Rachel Barnes, MRCS, MA Academic Department of Vascular Surgery, Hull Royal Infirmary/ Hull York Medical School
  More Information

No publications provided

Responsible Party: Daniel Carradice, Principle Investigator: Rachel Barnes, University of Hull
ClinicalTrials.gov Identifier: NCT01942941     History of Changes
Other Study ID Numbers: 12/EE/0314
Study First Received: September 4, 2013
Last Updated: September 10, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Ischemia
Ulcer
Varicose Veins
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 17, 2014