The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency

University of Miami

Status: Completed

Conditions: Chronic Venous Insufficiency

Treatments: Device: Sigvaris Compreflex Inelastic Compression Wrap

Study type: Interventional

Funder types: Other

Identifiers

NCT05051540

20210807

Details and patient eligibility

About

The purpose of this protocol is to measure the effect of the use of an inelastic compression system (ICS) on quality of life (QOL) in patients with chronic venous insufficiency (CVI) who have demonstrated limited or no compliance with prescribed compression stockings or bandage wraps.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is age 18 or older, able and willing to provide consent and agrees to comply with the study procedures
• Subject must have chronic venous insufficiency of stages C3, C4, or C5 according to the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification system
• Not compliant with their currently prescribed compression system

Exclusion criteria

• Active malignancy other than non-melanoma skin cancer
• Study ulcer suspicious for cancer
• Subjects who are pregnant and/or breastfeeding
• In the opinion of the PI the subject cannot comply with study procedures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Inelastic Compression System Group

Experimental group

Description:

Participants in this group will receive the inelastic compression wrap for daily use on their legs for 6 consecutive weeks.

Treatment:

Device: Sigvaris Compreflex Inelastic Compression Wrap