N/A
Completed N=349
VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)
Chronic Venous Insufficiency
Source: ClinicalTrials.gov NCT04757766 ↗
Enrolled (actual)
349
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy — 243 Participants
Summary
The VAP-PRO-C6 is a Russian multicenter observational program to be implemented at the routine visits and assessments. The program will include patients with chronic venous disease of CEAP classes C6. This program is planned to be carried out in Russia in 2021-2022.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy |
243 | — |
| PRIMARY Eeffectiveness of Systemic Pharmacotherapy |
247 | — |
| SECONDARY Healing of the Reference Venous Ulcers #1 |
47 | — |
| SECONDARY Healing of the Reference Venous Ulcers at Visit 3 vs Baseline |
8.02 | — |
Eligibility Criteria
Inclusion Criteria
- CVD documented by venous DUS
- Age over 18 years
- Written informed consent is provided
- No treatment with venoactive drugs within 4 weeks prior to inclusion in the study
- Presence of a primary /active venous ulcer (class C6/ CEAP) that meets criteria for the referent ulcer
- No surgical intervention or procedure (including sclerotherapy) for CVD is planned
Exclusion Criteria
- Withdrawal of the informed consent
- Pregnancy or willingness to become pregnant within at least 2 months after the end of the study
- Indications for surgery (including sclerotherapy)
- Serious violation or non adherence to the prescribed therapy/ regimen
- Use of prohibited drugs that can cause edema of lower extremities (calcium channel blockers, hormonal agents, NSAIDs, etc.)
Data sourced from ClinicalTrials.gov (NCT04757766). 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.