N/A
Completed N=30
The Effect of Inelastic Compression System on Quality of Life in People With Chronic Venous Insufficiency
Chronic Venous Insufficiency
Source: ClinicalTrials.gov NCT05051540 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Change in the Quality of Life as Measured by CIVIQ-20 — 12.2 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Quality of Life as Measured by CIVIQ-20 |
12.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05051540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.