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Surgical Revascularisation and Nerve Stimulation Trial (SRANS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01938924
Recruitment Status : Withdrawn (No funding)
First Posted : September 10, 2013
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hull and East Yorkshire Hospitals NHS Trust

Brief Summary:
A study to investigate if the gekoTM device improves flow through vascular bypass grafts

Condition or disease Intervention/treatment Phase
Peripheral Arterial Occlusive Disease Device: GekoTM Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Control Trial to Establish if Use of the gekoTM (Trademark) Post Infra-inguinal Surgical Vein Revascularisation Increases Flow Through the Graft
Study Start Date : September 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
No Intervention: No intervention
No intervention
Active Comparator: GekoTM
geko applied to bypass limb
Device: GekoTM
electrical neuromuscular stimulation




Primary Outcome Measures :
  1. Change in arterial blood volume flow in the bypass graft measured by ultrasound. [ Time Frame: 1 day ]
    Measured by ultrasound duplex


Secondary Outcome Measures :
  1. To assess effect on blood flow in the superficial femoral vein [ Time Frame: 1 day ]
    Measured by ultrasound doppler

  2. To assess effect on microcirculation [ Time Frame: 1 day ]
    Measured using laser Doppler flowmetry

  3. To assess effect on pulse wave velocity, cardiac output and stroke volume [ Time Frame: 1 day ]
    Measured using using the Vicorder device.

  4. To assess effect on levels of VEGF, PAI-1 and tPA antigen. [ Time Frame: 1 day ]
    Blood tests and ELISA

  5. To assess the impact of gekoTM device on pain score utilising the McGill Pain score [ Time Frame: 1 day ]
    Validated pain questionnaire

  6. Patient tolerance/ acceptability [ Time Frame: 1 day ]
    Questionnaire using Visual Analogue Scores and Verbal Rating Scores to be completed following removal of geko™ device

  7. To assess effect on calf circumference [ Time Frame: 1 day ]
    Measurement pre and post device



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years,
  2. Undergoing infra-inguinal vein bypass graft.
  3. Intact cutaneous sensations to nociception in the lower limb, as determined by the investigator.
  4. Intact healthy skin at site of application.
  5. On effective contraception if sexually active - oral contraceptive pill (> 3 months use), condoms, intrauterine contraceptive device, depot injection.
  6. Able to understand the Patient Information Sheet and capable and willing to give informed consent and follow the protocol requirements

Exclusion Criteria:

  1. History of haematological disorder or DVT within the preceding 6 months,
  2. Pregnant or planning to become pregnant during study duration,
  3. Pacemakers or implantable defibrillators,
  4. Use of any other neuro-modulation device,
  5. Current use of TENS in pelvic region, back or legs,
  6. Use of investigational drug/device therapy within past 4 weeks that may interfere with this study,
  7. Significant varicose veins or lower limb ulceration.
  8. Recent surgery (such as abdominal, gynaecological, hip knee replacement).
  9. Recent trauma to lower limbs.
  10. Chronic Obesity (BMI Index >34).
  11. Any medication judged to be significant by the Principal Investigator.
  12. Any significant illness during the four (4) weeks preceding the screening period of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938924


Locations
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United Kingdom
Hull Royal Infirmary
Hull, EastRiding Of Yorkshire, United Kingdom, HU3 2JZ
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Investigators
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Study Chair: Rachel Barnes, MRCS, MA Hull Royal Infirmary

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Responsible Party: Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01938924     History of Changes
Other Study ID Numbers: 12/YH/0480
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases