Efficacy and Safety of Regulatory Vascular Polypeptides in Chronic Venous Diseases of the Lower Extremities: Results of a Randomized Placebo-Controlled Study

Suchkov I.A.; Kamaev A.A.; Chupin A.V.; Sapelkin S.V.; Burenin A.G.

doi:https://doi.org/10.17116/flebo20262002189

Suchkov I.A.

Pavlov Ryazan State Medical University, Ryazan, Russia

SPIN RSCI: 6473-8662
Scopus AuthorID: 56001271800
ResearcherID: M-1180-2016
ORCID: 0000-0002-1292-5452

Kamaev A.A.

Pavlov Ryazan State Medical University, Ryazan, Russia

ORCID: 0000-0002-3979-1271

Chupin A.V.

Vishnevsky National Medical Research Center of Surgery, Moscow, Russia;
Russian Medical Academy for Continuous Professional Education, Moscow, Russia

ORCID: 0000-0002-5216-9970

Sapelkin S.V.

Vishnevsky National Medical Research Center of Surgery, Moscow, Russia

ORCID: 0000-0003-3610-8382

Burenin A.G.

PeptidePro, Moscow, Russia

ORCID: 0000-0001-6993-9700

Efficacy and Safety of Regulatory Vascular Polypeptides in Chronic Venous Diseases of the Lower Extremities: Results of a Randomized Placebo-Controlled Study

Authors:

Suchkov I.A., Kamaev A.A., Chupin A.V., Sapelkin S.V., Burenin A.G.

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Journal: Journal of Venous Disorders. 2026;20(2): 89‑96

DOI: 10.17116/flebo20262002189

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To cite this article:

Suchkov IA, Kamaev AA, Chupin AV, Sapelkin SV, Burenin AG. Efficacy and Safety of Regulatory Vascular Polypeptides in Chronic Venous Diseases of the Lower Extremities: Results of a Randomized Placebo-Controlled Study. Journal of Venous Disorders. 2026;20(2):89‑96. (In Russ.)
https://doi.org/10.17116/flebo20262002189

Подписка 2026 Флебология (Journal of Venous Disorders)

Использование инфографики авторами научных работ

OBJECTIVE

To evaluate the efficacy and safety of a therapeutic agent derived from regulatory polypeptides sourced from bovine vascular tissue in combination therapy for patients diagnosed with chronic venous diseases (CVD) in the lower extremities.

MATERIAL AND METHODS

This multicenter, randomized, double-blind, placebo-controlled trial involved 190 patients with CVD, randomly assigned to two groups. Group 1 received a combination of vascular polypeptides and troxerutin (n=95), while Group 2 received placebo with troxerutin (n=95). The total duration of the observation period extended to 137 days. This period included five scheduled visits: Visit 1 at the start of therapy; Visit 2 after 14±2 days of treatment; Visit 3 at the end of the treatment (35±2 days); Visit 4 30±3 days after the end of the treatment; and Visit 5 90±5 days after the end of the treatment. Efficacy was evaluated using the Venous Clinical Severity Score (VCSS), and pain and discomfort were quantified using the Visual Analog Scale (VAS). Quality-of-life outcomes were measured using the CIVIQ-20 questionnaire, and changes in malleolar circumference were recorded. Safety was assessed by the frequency and types of adverse events.

RESULTS

At Visit 4, the mean VCSS in Group 1 was 2.33±1.31, compared to 3.24±1.62 in Group 2, resulting in a mean difference of –0.92 (95% CI from –1.34 to –0.50; p<0.001), confirming the hypothesis of the efficacy of the combination therapy. At Visit 4, a clinically significant improvement in quality of life, defined as a reduction of 5 points or more on the CIVIQ-20, was observed in 93.7% of patients in Group 1, compared with 75.8% in Group 2 (p=0.0006). This effect persisted at Visit 5, with improvements noted in 92.6% in Group 1 compared to 78.9% in Group 2 (p=0.007). Additionally, a reduction of at least 1 point in pain intensity on the VAS was observed in 91.6% of patients in Group 1, compared with 74.7% in Group 2 (p=0.002). Malleolar circumference exhibited a greater reduction in Group 1 at Visit 5 (0.76±0.79 cm vs. 0.46±0.64 cm; p=0.004). No serious adverse events were reported throughout the study.

CONCLUSIONS

Incorporating bovine regulatory vascular polypeptides into a combined therapeutic approach effectively alleviates symptoms of chronic venous disease and enhances quality of life while maintaining a favorable safety profile.

Keywords:

chronic venous disease

varicose veins

bovine regulatory vascular polypeptides

VCSS

CIVIQ-20

Authors:

Suchkov I.A.

Pavlov Ryazan State Medical University, Ryazan, Russia

SPIN RSCI: 6473-8662
Scopus AuthorID: 56001271800
ResearcherID: M-1180-2016
ORCID: 0000-0002-1292-5452

Kamaev A.A.

Pavlov Ryazan State Medical University, Ryazan, Russia

ORCID: 0000-0002-3979-1271

Chupin A.V.

Vishnevsky National Medical Research Center of Surgery, Moscow, Russia;
Russian Medical Academy for Continuous Professional Education, Moscow, Russia

ORCID: 0000-0002-5216-9970

Sapelkin S.V.

Vishnevsky National Medical Research Center of Surgery, Moscow, Russia

ORCID: 0000-0003-3610-8382

Burenin A.G.

PeptidePro, Moscow, Russia

ORCID: 0000-0001-6993-9700

Received:

04.03.2026

Accepted:

19.03.2026

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