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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices

NCT03420625

Venous Stasis Deep Vein Thrombosis

COMPLETED NA

Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device

NCT02031627

Lower Extremity Lymphoedema Leg Lymphoedema

COMPLETED NA

Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation

NCT02101645

Patients With Lower Extremity Venous Ulcers Patients With Localized Edema

COMPLETED NA

Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device

NCT01592812

Peripheral Artery Disease

COMPLETED PHASE4

Shockwave Therapy in Lower Limb Intermittent Calf Claudication

NCT02652078

Peripheral Vascular Disease

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease.

OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects.

METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intermittent Pneumatic Compression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Half of recruited subjects (n=5)

Group Type EXPERIMENTAL

Neuromuscular stimulation, followed by intermittent pneumatic compression

Intervention Type DEVICE

Group 2

Other half of recruited subjects (n=5)

Group Type EXPERIMENTAL

Intermittent pneumatic compression, followed by neuromuscular stimulation

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuromuscular stimulation, followed by intermittent pneumatic compression

Intervention Type DEVICE

Intermittent pneumatic compression, followed by neuromuscular stimulation

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Device 1 followed by a break, followed by device 2 Device 2, followed by a short break then device 2

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes