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Completed

NCT Number: NCT03420625

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

In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities in order to identify those which most effective than the others.

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Key information

Conditions

Venous Stasis Cardiovascular Diseases Deep Vein Thrombosis Embolism and Thrombosis Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Thrombosis Varicose Ulcer Varicose Veins Vascular Diseases Venous Thrombosis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Three Intermittent Pneumatic Compression (IPC) devices were selected: Foot-IPC, rapid Calf-IPC and a slow, sequential Calf-IPC. A Neuromuscular Electrical Stimulation (NMES) device was also used in the calf. Blood flow measurements in the right popliteal vein of ten healthy individuals were performed using Doppler ultrasound before (control) and while using IPC or NMES. The blood flow parameters measured where: peak systolic velocity (cm/s), time-averaged mean velocity (cm/sec), volume flow (ml/min) and ejected volume per individual stimulus (ml). The tolerability of each device was also assessed using an analogue scale from zero to ten. Differences between modalities regarding the pattern as well as the absolute values of velocity and volume are being assessed. Power calculation: Recent studies showed that the peak venous velocity (PV) at baseline is around 11 cm/s and after applying foot-IPC the PV rises to 50 cm/s with a maximum standard deviation of 15 (Broderick et all, 2014). Thus, three patients per group would be required to detect a difference of 39 cm/s in PV (two-sided type-I error rate = 5%; power = 80%). To reach an even higher power we choose to include 10 patients in study, which resulted in a power of 99.7% for the above calculation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • pregnancy
  • previous lower limb operation involving the vascular system
  • current thromboprophylactic or thrombolytic therapy
  • vascular abnormalities in the lower limbs
  • cardiorespiratory or renal failure causing pitting oedema

Treatment and study plan

Foot IPC

Device

Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA

Other names: Intermittent pneumatic compression in the foot

Rapid calf IPC

Device

Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA

Other names: Rapid Intermittent pneumatic compression in the calf

Slow calf IPC

Device

Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA

Other names: Slow Intermittent pneumatic compression in the calf

Calf NMES

Device

Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator

Other names: Calf neuromuscular electrical stimulation

Primary outcomes

  1. Blood Flow - Peak Systolic Velocity (cm/Sec)

    Time frame: up to one hour in total

    With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.

  2. Blood Flow - Time-averaged Mean Velocity (cm/Sec)

    Time frame: up to one hour in total

    With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.

  3. Blood Flow - Volume Flow (ml/Min)

    Time frame: up to one hour in total

    With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.

  4. Blood Flow - Ejected Volume Per Individual Stimulus (ml)

    Time frame: up to one hour in total

    With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.

Secondary outcomes

  1. Tolerability to IPC and NMES According to Visual Analogue Scale 0-10

    Time frame: one minute

    All subjects will be asked to subjectively grade each modality according to how comfortable or uncomfortable it felt under the time was applied to the subject according to Visual Analogue Scale 0-10. The following description will be given to the subjects: 0 denotes the the modality was totally intolerable, 10 denotes that the modality is very pleasant to use and 5 denotes neither pleasant nor unpleasant feeling.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Haemodynamic Effects of Different Mechanical Compression Devices and Neuromuscular Stimulation in the Lower Limb

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2018
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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