The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02552420

Enrollment

128

Registered

2015-09-17

Start date

2007-09-30

Completion date

2015-07-31

Last updated

2015-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Venous Thrombosis

Keywords

infrared thermal imaging, deep venous thrombosis

Brief summary

The purpose of this study is to determine the effectiveness of infrared thermal imaging in adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

1. Willing to participate in the trial and sign the informed consent form, 2. Aged: 18-75 years. They had been definitively diagnosed with venous thromboembolism, 3. The bed-rest immobilization time should be more than 72 hours, 4. Planing to gynecology operation, 5. The D dimer should be more than500 g • L-1, 6. There is no obvious symptoms of systemic infection two weeks before the test, 7. There is no trauma, infection, biopsy or puncture, hemorrhage and tumor in the corresponding detection site (chest and lower limbs), 8. There is no skin disease, heart, liver, kidney, gastrointestinal tract, hematopoietic system and mental, neurological has no serious diseases.

Exclusion criteria

1. Patients can not be good partners, 2. Doctors believe that there is any inappropriate situations.

Design outcomes

Primary

Measure	Time frame	Description
Using the Infrared Thermal Imaging to detecting Venous Thromboembolism	up to 24 months	① Different levels of pseudocode (white, red, pink, yellow, green, blue, black) representing related IRTI that corresponds to a color scale bar of low to high temperatures, so we can know disease's position, extent and severity by comparing with the difference of color distribution and shape in the thermal imaging. ②The intensity of thermal distribution is higher than normals (great than or equal 0.5 Celsius degree is unnoraml), the symmetry of thermal range is relatively increased (pixels over 0.5 \ 1.0-fold), the difference of spatial distribution of the thermal field and the difference of statistically analyze are related to the disease.

Outcome results