A Comparison of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease
NCT ID: NCT03630185
Last Updated: 2020-02-17
Study Results
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View full resultsBasic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2017-04-25
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Custom-manufactured compression hosiery (Isobar)
The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb.
Custom-manufactured compression hosiery (Isobar)
The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb.
Off-the-rack stockings (Sigvaris)
Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb.
Off-the-rack stockings (Sigvaris)
Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb.
Interventions
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Custom-manufactured compression hosiery (Isobar)
The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb.
Off-the-rack stockings (Sigvaris)
Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb.
Eligibility Criteria
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Inclusion Criteria
* Patient is participating in usual work and home activities with no changes anticipated for the duration of the study
* The use of compression stocking is prescribed in accordance with the usual practice and management of venous disorders
* The patient will confirm they are willing to pay for the compression stockings.
Exclusion Criteria
* The patient has non-venous source of pain in either leg that could, in the opinion of the investigator, confound the results of the study i.e.Neuropathy, Arterial insufficiency, Diabetes
* The patient is confined to bed
* The patient has uncontrolled Congestive Heart Failure
* The patient has acute dermatitis
* The patient has weeping dermatosis
* Patients with venous ulcers will be excluded.
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Stuart A Harlin
Associate Professor
Principal Investigators
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Stuart A Harlin, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC-MS-17-0015
Identifier Type: -
Identifier Source: org_study_id
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