Clinical Research
Chronic venous insufficiency (CVI) results from chronic venous hypertension in the lower extremities. Depending on the severity and duration of disease, CVI may manifest as pain, lower extremity edema, hyperpigmentation, eczematous dermatitis, lipodermatosclerosis, atrophie blanche, and ulcerations. First line therapy for all stages of CVI is compression, usually with stockings. However, patient adherence is low, creating a barrier to clinical improvement and quality of life. We hypothesized that a novel, inelastic compression wrap system will improve Quality of Life (QoL) in patients with CVI who have been unsuccessful with compression stockings in the past.
We conducted an open label, single center, non-blinded, prospective cohort study. Adults with CVI who were non-compliant with their compression device were prescribed the novel inelastic compression wrap system. Study assessments were performed on Day 1, when patients receive the compression wrap, and at week 6. The primary endpoint of the study was the change QoL over 6 weeks of therapy as measured by the CIVIQ-20 scale.
Thirty patients completed the study (age 46-90 years). Of these, 56.7% (n=17) were females. At six weeks, CIVIQ-20 GIS scores demonstrated an average improvement of 12.1 points on a 0-100 scale (p=0.0019). SF-36 scores improved across 7 of the 9 domains. Additionally, calf circumference (p=0.0009), itch levels (p=0.0008), and the Venous Clinical Severity Score (p=0.0029) improved over 6 weeks.
Untreated CVI may lead to worsening of disease and ultimately ulceration. The mainstay of therapy is compression with stockings however, many patients cannot use stockings. Here, we demonstrated that novel inelastic compression wraps improved QoL in patients with CVI who failed treatment with compression stockings. The results of this study indicate that compression wrap systems could provide a functional and comfortable compression therapy for patients with CVI who may otherwise go untreated. The QoL improvement from use of the inelastic compression wrap system may increase adherence to compression therapy which in turn will improve outcomes.