Peripheral Vascular Disease and Nerve Stimulation (CCLINS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Carradice, University of Hull
ClinicalTrials.gov Identifier:
NCT01942941
First received: September 4, 2013
Last updated: May 29, 2014
Last verified: May 2014
  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
Study Completion Date: May 2014
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942941

Locations
United Kingdom
Hull Royal Infirmary
Hull, EastRiding of Yorkshire, United Kingdom, HU3 2JZ
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: May 29, 2014
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 July 26, 2014