Peripheral Vascular Disease and Nerve Stimulation

NCT01942941 | Completed DMC

• 1 other identifier: 12/EE/0314
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critical Limb Ischaemia; Claudication; Ulcers; Varicose Veins; Post Angioplasty

Outcome Measures

Primary Outcomes (1)

• Effect of geko™ on blood volume flow through the femoral artery

  Measured with ultrasound doppler

  Study day i.e. 1 day

Secondary Outcomes (6)

• Effect of geko™ on venous blow flow

  Study day i.e. 1 day

• Effect of geko™ on microcirculatory flow

  Study day i.e. 1 day

• Establish whether effects of geko™ are local or systemic

  Study day i.e. 1 day

• Effect of geko™ on patients symptoms

  study day i.e. 1 day

• Acceptability and tolerability of geko™ device

  study day i.e. 1 day

Study Arms (1)

geko™ electrical stimulation

EXPERIMENTAL

Applied to stimulate peroneal nerve unilaterally

Device: geko™ electrical stimulation

Interventions

geko™ electrical stimulation DEVICE

applied to stimulate peroneal nerve and cause active muscle twitch

geko™ electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull Royal Infirmary

Hull, EastRiding of Yorkshire, HU3 2JZ, United Kingdom

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Intermittent Claudication; Ulcer; Varicose Veins

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Signs and Symptoms

Study Officials

• Rachel Barnes, MRCS, MA

  Academic Department of Vascular Surgery, Hull Royal Infirmary/ Hull York Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 16, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

GB (1)