Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics

NCT01939288 | Completed Results DMC

• 1 other identifier: JROHH0324
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

What is known?

• Disorders of peripheral circulation result in vascular morbidity and mortality
• Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease
• The benefit of intermittent pneumatic compression is clinically well evidenced.
• The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source. What new information will this trial contribute? \- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation

Conditions

Intermittent Pneumatic Compression

Keywords

neuromuscular stimulation; intermittent pneumatic compression

Outcome Measures

Primary Outcomes (1)

• IPC(on) Peak Velocity Change From Baseline

  Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery

  One day

Other Outcomes (1)

• NMES(on) Peak Velocity Change From Baseline

  One day

Study Arms (2)

Group 1

EXPERIMENTAL

Half of recruited subjects (n=5)

Device: Neuromuscular stimulation, followed by intermittent pneumatic compression

Group 2

EXPERIMENTAL

Other half of recruited subjects (n=5)

Device: Intermittent pneumatic compression, followed by neuromuscular stimulation

Interventions

Neuromuscular stimulation, followed by intermittent pneumatic compression DEVICE

Also known as: Device 1 followed by a break, followed by device 2

Group 1

Intermittent pneumatic compression, followed by neuromuscular stimulation DEVICE

Also known as: Device 2, followed by a short break then device 2

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 yrs, Body Mass Index (BMI) 17-30Kg/m2

You may not qualify if:

• History of heart disease or respiratory disorder, pregnancy, history of peripheral vascular disease or previous thromboembolic event, ABPI\< 0.9, cardiac pacemaker, history of leg fractures and/or presence of metal implants in the leg, long distance travel within one week prior to study

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Academic Vascular Surgery, Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (1)

• 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 RESULT

Related Links

• PI information

Results Point of Contact

• Title: Miss Katherine Williams
• Organization: Imperial College London

k.williams@imperial.ac.uk

020 3311 7335

Study Officials

• Kate Williams

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: September 11, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 20, 2019
• Results First Posted: July 22, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)