A Comparison of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease

The University of Texas System (UT)

Status: Terminated

Conditions: Venous Disease

Treatments: Device: Off-the-rack stockings (Sigvaris); Device: Custom-manufactured compression hosiery (Isobar)

Study type: Interventional

Funder types: Other

Identifiers

NCT03630185

HSC-MS-17-0015

Details and patient eligibility

About

The purpose of this research study is to assess the efficacy of custom-manufactured compression hosiery (also known as compression stockings) compared to similar off-the-rack (OTR) compression stockings.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to comprehend and sign an informed consent and complete study questionnaires
• 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 a known allergy to any component of the stocking (latex, etc)
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

Custom-manufactured compression hosiery (Isobar)

Experimental group

Description:

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.

Treatment:

Device: Custom-manufactured compression hosiery (Isobar)

Off-the-rack stockings (Sigvaris)

Active Comparator group

Description:

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.

Treatment:

Device: Off-the-rack stockings (Sigvaris)