NCT01979328

Brief Summary

The primary objective of this study is to examine the flow characteristics of deep venous flow in the leg veins using Doppler ultrasound imaging and how this flow is modified by the application of a plaster and with a geko™ device in healthy volunteers

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
Last Updated

November 8, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

October 21, 2013

Last Update Submit

November 4, 2013

Conditions

Deep Vein Thrombosis

Keywords

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Blood flow

    4 hours

Secondary Outcomes (1)

  • microcirculatory blood flow

    4 hours

Other Outcomes (1)

  • acceptability and tolerance (composite endpoint)

    4 hours

Study Arms (1)

Study arm

EXPERIMENTAL

geko neuromuscular electrostimulation

Device: gekoDevice: Plaster cast

Interventions

gekoDEVICE
Study arm
Plaster castDEVICE
Study arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be in good general health and fitness.
  • Aged between 18 and 65 years.
  • Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders or indications), screening physical examination, vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) and duplex ultrasound)
  • BMI between 18 and 34
  • No history or signs of drug abuse (including alcohol), licit or illicit.
  • Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the thirty (30) days preceding the study, and agrees not to use any medications during the course of the study without informing the Research Team.
  • Able to understand the Volunteer Information Sheet and signed the written Informed Consent Forms.
  • Able and willing to follow the Protocol requirements.

You may not qualify if:

  • Previous leg fracture. (within the last 12 months)
  • Any evidence of organ dysfunction, or any clinically significant deviation from normal in the physical determinations.
  • History or signs of haematological disorders (especially in relation to clotting or coagulation or previous Deep or superficial vein thrombosis/pulmonary embolism) or familiar history of such.
  • Peripheral arterial disease (ABPI\<0.9), clinically significant varicose veins or lower limb ulceration.
  • Musculoskeletal disorders (such as pain during exercise of lower limb, rheumatoid or osteoarthritis).
  • Neurological disorders,(such as stroke, multiple sclerosis)
  • Recent surgery (such as abdominal, gynaecological, hip knee replacement).
  • Recent trauma to lower limbs.
  • Chronic Obesity (BMI Index \>34).
  • Pregnancy.
  • Any Medication judged to be significant by the Principal Investigator.
  • Tobacco consumption
  • History of disorders of the gastrointestinal, hepatic, renal, cardiovascular, endocrine, neurological, dermatological, rheumatologic, metabolic (including diabetes), psychiatric, haematological (especially in relation to clotting or coagulation), or systemic disease judged to be significant.
  • A pulse rate of less than 50 beats/minute, a sitting systolic blood pressure \>160 or \<80 mmHg and/or a sitting diastolic pressure of \>90 or \<60 mmHg.
  • Any significant illness during the four (4) weeks preceding the screening period of the study.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southampton University Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

  • Warwick DJ, Shaikh A, Gadola S, Stokes M, Worsley P, Bain D, Tucker AT, Gadola SD. Neuromuscular electrostimulation viathe common peroneal nerve promotes lower limb blood flow in a below-kneecast: A potential for thromboprophylaxis. Bone Joint Res. 2013 Sep 2;2(9):179-85. doi: 10.1302/2046-3758.29.2000176. Print 2013.

    PMID: 23999610RESULT

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2013

First Posted

November 8, 2013

Study Start

March 1, 2012

Primary Completion

May 1, 2012

Last Updated

November 8, 2013

Record last verified: 2013-10

Locations

GB(1)