[Objective control over efficacy of therapy for trophic skin disorders in chronic venous insufficiency of lower limbs].

Abstract

Background: Objective control of alterations in indurated cellulitis and lipodermatosclerosis, as well as correlation of these conditions with other venospecific symptoms caused by chronic venous insufficiency appear to be a poorly explored but at the same time currently important problem.

Objective: The purpose of this study was to assess efficacy of combined compression and pharmacological therapy in patients with chronic venous insufficiency of lower limbs of clinical classes C4a and C4b according to CEAP in routine clinical practice.

Patients and methods: This prospective observational study enrolled a total of 381 patients with CEAP class C4a, b chronic venous insufficiency, undergoing for 6 months combined conservative treatment. The basic therapy consisted in standardized compression with pharmacological phlebotropic support (micronized purified flavonoid fracture - MPFF). Therapeutic efficacy was assessed based on the dynamics of venospecific symptoms, using visual analog scales (VAS), CEAP classification with the application of the Venous Clinical Severity Score (VCSS), as well as the Chronic Venous Insufficiency Questionnaire (CIVIQ-14). The state of soft tissues in the area of trophic disorders in all patients was objectively assessed by measuring subcutaneous-fat thickness by means of ultrasonographic examination. In 55 patients, we additionally used durometry, and in 60 patients - curvimetry.

Results: Of the 381 patients initially included into the study, 365 subjects fully completed it. At 6 months, subcutaneous adipose tissue thickness, VCSS and VAS improved significantly (p<0.001 for all evaluated parameters). The number of patients with C4b clinical class decreased by 6.9% compared with the baseline level. Besides, there was a significant decrease in the borders of the zone of trophic disorders (p<0.001), skin hardness (p=0.002), with significant improvement of quality of life by the CIVIQ-14 scores. There were no adverse reactions requiring discontinuation of treatment.

Conclusion: Combined conservative therapy including compression and administration of MPFF in the observed group of patients significantly improved the condition of the skin and soft tissues in patients with CEAP C4a, b chronic venous insufficiency. The dynamics of venospecific symptoms directly correlated with the condition of the skin and subcutaneous fat, evaluated by means of instrumental methods, which may be used in real clinical practice. Registration number of the study: ClinicalTrials.gov identifier, NCT04138576.