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

NCT03420625 | Completed Results

• 1 other identifier: SW2016-17-HEMOD
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Venous Stasis; Deep Vein Thrombosis

Keywords

Intermittent Pneumatic Compression Devices; Electric Stimulation Therapy; Blood Flow Velocity; Hemodynamics

Outcome Measures

Primary Outcomes (4)

• Blood Flow - Peak Systolic Velocity (cm/Sec)

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

  up to one hour in total

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

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

  up to one hour in total

• Blood Flow - Volume Flow (ml/Min)

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

  up to one hour in total

• Blood Flow - Ejected Volume Per Individual Stimulus (ml)

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

  up to one hour in total

Secondary Outcomes (1)

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

  one minute

Study Arms (4)

Foot IPC

ACTIVE COMPARATOR

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

Device: Foot IPC

Rapid calf IPC

ACTIVE COMPARATOR

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

Device: Rapid calf IPC

Slow calf IPC

ACTIVE COMPARATOR

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

Device: Slow calf IPC

Calf NMES

ACTIVE COMPARATOR

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

Device: Calf NMES

Interventions

Foot IPC DEVICE

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

Also known as: Intermittent pneumatic compression in the foot

Foot IPC

Rapid calf IPC DEVICE

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

Also known as: Rapid Intermittent pneumatic compression in the calf

Rapid calf IPC

Slow calf IPC DEVICE

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

Also known as: Slow Intermittent pneumatic compression in the calf

Slow calf IPC

Calf NMES DEVICE

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

Also known as: Calf neuromuscular electrical stimulation

Calf NMES

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

MeSH Terms

Conditions

Varicose Ulcer; Venous Thrombosis

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Thrombosis; Embolism and Thrombosis

Results Point of Contact

• Title: Dr. Paul Ackermann
• Organization: Karolinska University Hospital

paul.ackermann@sll.se

+46 8 517 700 00

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 5, 2018
• Study Start: September 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 23, 2020
• Results First Posted: February 12, 2019

Record last verified: 2020-09