Blood Flow Changes in Femoral-popliteal Bypass Grafts After Neuromuscular Electrical Stimulation (NMES).

NCT04109287 | Withdrawn

• 1 other identifier: 19CX5468
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The muscles of the leg require a regular supply of oxygen and nutrients. This is supplied by blood carried by a network of large blood vessels known as arteries. Gradually, these arteries can become narrowed or blocked by a build-up of fatty deposits. This process is known as atherosclerosis and leads to a condition called peripheral arterial disease. The restriction of blood flow caused by the blockage prevents exercising muscles getting enough oxygen and nutrients. In some people, this may lead to a painful ache in their legs when they walk, known as intermittent claudication. If the leg pain is severe, surgeons may decide to bypass this blockage using a vein taken from another part of the body, thereby improving blood flow to the foot. Patients with a narrowing or blockage anywhere in the main artery that runs from the groin to the back of the knee may be treated with a particular type of bypass graft known as a femoral-popliteal bypass graft. However, this graft may collapse if not enough blood is flowing through it. This study is looking to see whether a circulation booster machine, known as the REVITIVE® device, can improve the amount of blood flowing through femoral-popliteal bypass grafts. Patients with these grafts attending their usual clinic appointment in the Vascular Outpatients department at Charing Cross Hospital, London will be asked to have their leg scanned using an ultrasound machine to measure the amount of blood flowing through the graft. They will then use the REVITIVE® device for 30 minutes, before being re-scanned to see whether the device has improved blood flow. Improvements in blood flow may suggest a promising role for the device in keeping these grafts open, therefore helping them last longer and potentially reducing the leg pain associated with peripheral arterial disease.

Conditions

Peripheral Arterial Disease; Peripheral Artery Disease; Peripheral Vascular Disease; Femoral Popliteal Occlusion

Keywords

Femoral-popliteal; Bypass; Graft; PAD; PVD; NMES; Time-averaged mean velocity; Volume flow rate; Volume flow; TAMV; VFR; Peak systolic velocity; PSV; Peak velocity; PV; Neuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (3)

• Change in time-averaged mean velocity (TAMV).

  Change in TAMV in femoral-popliteal bypass grafts after use of the NMES device.

  1 to 3 hours

• Change in peak systolic velocity (PSV).

  Change in PSV in femoral-popliteal bypass grafts after use of the NMES device.

  1 to 3 hours

• Change in volume flow rate (VFR).

  Change in VFR in femoral-popliteal bypass grafts after use of the NMES device.

  1 to 3 hours

Secondary Outcomes (6)

• Intra-subject reliability measurements of time-averaged mean velocity (TAMV).

  1 to 3 hours

• Intra-subject reliability measurements of peak systolic velocity (PSV).

  1 to 3 hours

• Intra-subject reliability measurements of volume flow rate (VFR).

  1 to 3 hours

• Inter-user reliability measurements of time-averaged mean velocity (TAMV).

  1 to 3 hours

• Inter-user reliability measurements of peak systolic velocity (PSV).

  1 to 3 hours

Study Arms (1)

Two ultrasound scans and activation of NMES device

EXPERIMENTAL

Participants will have their leg scanned using an ultrasound machine, before being asked to use the REVITIVE® device for 30 minutes. Their leg will then be scanned again.

Device: REVITIVE® device

Interventions

REVITIVE® device DEVICE

The REVITIVE® device applies neuromuscular electrical stimulation to the soles of the feet, causing the muscles of the leg to contract and relax, thus improving blood circulation through the legs.

Two ultrasound scans and activation of NMES device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a confirmed diagnosis of peripheral arterial disease (PAD);
• Have undergone revascularisation surgery via a vein femoral-popliteal bypass graft;
• Are willing to participate and are able to provide written informed consent;
• Are aged over 18 years;
• Agree to attend at least one of their usual clinic appointments at the Vascular Outpatients department at Charing Cross Hospital, London before 13th April 2020 (project deadline for the student is Monday 11th May 2020);
• Have a body mass index (BMI) between 17 and 30 kg/m2.

You may not qualify if:

• Do not have a diagnosis of PAD;
• Have not had revascularisation surgery;
• Have had revascularisation surgery via an artificial femoral-popliteal bypass graft;
• Are fitted with an electronic implanted device;
• Are being treated for (or have symptoms of) a deep vein thrombosis (DVT);
• Are pregnant.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (5)

• Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.

  PMID: 24722790 BACKGROUND

• Varatharajan L, Williams K, Moore H, Davies AH. The effect of footplate neuromuscular electrical stimulation on venous and arterial haemodynamics. Phlebology. 2015 Oct;30(9):648-50. doi: 10.1177/0268355514542682. Epub 2014 Jul 4.

  PMID: 24997200 BACKGROUND

• Liu HI, Currier DP, Threlkeld AJ. Circulatory response of digital arteries associated with electrical stimulation of calf muscle in healthy subjects. Phys Ther. 1987 Mar;67(3):340-5. doi: 10.1093/ptj/67.3.340.

  PMID: 2950528 BACKGROUND

• Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised Controlled Trial: Potential Benefit of a Footplate Neuromuscular Electrical Stimulation Device in Patients with Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2017 Jan;53(1):114-121. doi: 10.1016/j.ejvs.2016.09.015. Epub 2016 Dec 2.

  PMID: 27919609 BACKGROUND

• Delis KT, Knaggs AL, Sonecha TN, Zervas V, Jenkins MP, Wolfe JH. Lower limb venous haemodynamic impairment on dependency: quantification and implications for the "economy class" position. Thromb Haemost. 2004 May;91(5):941-50. doi: 10.1160/TH03-12-0754.

  PMID: 15116255 BACKGROUND

Related Links

• Dhand, N.K. and Khatkar, M.S. (2014). Statulator: An online statistical calculator. Sample Size Calculator for Comparing Two Paired Means.

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alun H Davies, FHEA FACPh

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All participants will be scanned, asked to use the NMES device for 30 minutes and scanned again.

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 30, 2019
• Study Start: February 11, 2020
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Access requests will be reviewed by the PI.

Locations

GB (1)