Sulodexide in the Treatment of Chronic Primary Venous Disease of the Lower Extremities

NCT05005052 | Unknown Phase 3 DMC

• 1 other identifier: 2021-002311-64
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 19

Brief Summary

This study compares the efficacy and safety of sulodexide (Vessel) to placebo in patients with chronic venous disease of the lower extremities. The primary hypothesis is that more patients will achieve a decrease in rVCSS score of at least 4 points with sulodexide than with placebo.

Conditions

Chronic Venous Disease; Chronic Insufficiency Venous

Keywords

sulodexide; venoactive drug; venous disease; randomized; blinded; CEAP; ultrasonography; angiology; conservative treatment; quality of life; productivity loss; EQ-5D; CIVIQ-20

Outcome Measures

Primary Outcomes (1)

• Revised Venous Clinical Severity Score (rVCSS)

  A minimal decrease in rVCSS score by 4 points will be considered a clinically significant response to treatment.

  24 weeks of treatment

Secondary Outcomes (8)

• Revised Venous Clinical Severity Score (rVCSS)

  4, 8 and 12 weeks of treatment

• Volume in lower limb

  4, 8, 12 and 24 weeks of treatment

• Visual Analogue Scale (VAS)

  4, 8, 12 and 24 weeks of treatment

• Work Productivity and Activity Impairment (WPAI questionnaire)

  8 and 24 weeks of treatment

• EQ-5D questionnaire

  8 and 24 weeks of treatment

Study Arms (2)

Sulodexide arm

EXPERIMENTAL

Name: Vessel (medicinal product registered in Italy) Dosage form: soft capsules Active substance: sulodexidum 250 LSU Dosage: 2 x 2 soft capsules daily (oral use), in line with the labelled posology (500 LSU twice a day) Duration: 24 ± 4 weeks

Drug: Vessel

Placebo arm

PLACEBO COMPARATOR

Dosage form: soft capsules Appearance: undistinguishable from the active Dosage regimen: 2 x 2 soft capsules daily Duration of placebo intake: a total of 24 ± 4 weeks

Drug: Placebo

Interventions

Vessel DRUG

Sulodexide has protective effect on the endothelium, antithrombotic, fibrinolytic and anti-inflammatory effects. In the last 20 years, it has been well established in the common practice and its efficacy and safety have been demonstrated notably in the treatment of venous diseases such as post-thrombotic syndrome of the lower extremities, secondary prevention of deep and superficial venous thrombosis, supportive treatment of leg venous ulceration, ischemic disease of the lower limbs; symptomatic therapy of intermittent claudication, treatment of diabetic ulcers and microcirculation disorders of various aetiology. Patients with CVD were shown to respond quickly to sulodexide therapy in single arm observational studies. Sulodexide seems to provide both symptomatic and causal therapy.

Sulodexide arm

Placebo DRUG

Placebo and no compression or venopharmaceutical regimen

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed primary venous disease of the lower limbs in stage C2 - C6 according to the CEAP classification, clinical involvement of the venous system of the lower limbs is verified by duplex ultrasonography
• Presence of objective and subjective symptoms of the disease (classified according to rVCSS score ≥ 4)
• At the time of the enrolment, patient is not using nor planning to use compression therapy from his own decision or the decision of the treating physician
• Patient over 18 years of age
• Male or female patient of non-childbearing potential, i.e.: post-menopausal (at least 2 years without spontaneous menses) or surgically sterile (bilateral tubal occlusion or hysterectomy or ablation of both ovaries); OR of childbearing potential but with a negative pregnancy test result at Visit 1 AND agrees to use a highly effective method of contraception

You may not qualify if:

• Use of a drug with venoactive effect in the last month
• Regular use of compression therapy or use of mechanical devices for reduction of oedema in the last month
• Heart Failure as per NYHA III and IV, congestive heart failure with peripheral oedemas
• Chronic kidney disease with GF \< 30 ml/min (\< 0,5 ml/s) and/or proteinuria \> 0,5 g/24 hours, nephrotic syndrome, renal oedemas
• Advanced liver disease (Child-Pugh B and C or laboratory values of ALT or AST more than 3 times upper limit of normal range)
• Deep venous thrombosis lower limb thrombosis and / or documented residual venous obstruction or deep venous reflux due to post-thrombotic changes in the deep venous system
• Superficial venous thrombosis of the lower limbs in the previous 6 months
• Congenital venous / venolymphatic venous malformation
• Neuropathy of any aetiology
• Diabetic foot syndrome
• Refractory (uncontrollable) arterial hypertension (inability to achieve therapeutically systolic blood pressure ≤ 160 mmHg or diastolic blood pressure ≤ 100 mmHg)
• Symptomatic ischemic disease of lower limbs
• Lymphoedema: primary, posttraumatic, postoperative, post-radiation, malignant
• Manual/instrumental lymphatic drainage in the last 6 months
• Invasive procedure on the lower limbs in the last 6 months

Sponsors & Collaborators

• Value Outcomes Ltd.: lead
• Alfasigma S.p.A.: collaborator

Study Sites (19)

CardioVasc s.r.o.

Mladá Boleslav, Central Bohemia, 29301, Czechia

RECRUITING

Oblastní nemocnice Mladá Boleslav, a.s.

Mladá Boleslav, Central Bohemia, 29301, Czechia

RECRUITING

Phlebomedica s.r.o.

Říčany, Central Bohemia, 25131, Czechia

RECRUITING

Angionika s.r.o.

Slaný, Central Bohemia, 27401, Czechia

RECRUITING

Cor et Vasa s.r.o

Český Těšín, Moravskoslezský kraj, 737 01, Czechia

RECRUITING

Angiologická ambulance s.r.o.

Hlučín, Moravskoslezský kraj, 748 01, Czechia

TERMINATED

Angiologie Opava s.r.o.

Opava, Moravskoslezský kraj, 74601, Czechia

RECRUITING

Pedicor s.r.o.

Ostrava, Moravskoslezský kraj, 70030, Czechia

RECRUITING

Péče o cévy s.r.o.

Ostrava, Moravskoslezský kraj, 70800, Czechia

RECRUITING

Chirurgická ambulance MUDr. Prokop

Ostrava, Moravskoslezský kraj, 70900, Czechia

TERMINATED

Cordesora s.r.o.

Olomouc, Olomoucký kraj, 77900, Czechia

RECRUITING

Angios s.r.o.

Prostějov, Olomoucký kraj, 79601, Czechia

RECRUITING

REAGINTA sro

Přerov, Olomoucký kraj, 75002, Czechia

RECRUITING

CTC Hodonín s.r.o.

Hodonín, South Moravian, 69501, Czechia

RECRUITING

MUDr. Jan KVASNIČKA,CSc., Ordinace pro choroby srdce a cév

Prague, 101 00, Czechia

RECRUITING

Žilní klinika

Prague, 12000, Czechia

TERMINATED

FLEBODERMA, s.r.o.

Prague, 130 00, Czechia

RECRUITING

Cévní ambulance - Poliklinika Modřany

Prague, 14300, Czechia

RECRUITING

MUDr.Simon Jirát s.r.o. - Angiologie Zbraslav

Prague, 15600, Czechia

TERMINATED

Central Study Contacts

Jan Tužil

CONTACT

00420727824059; jan.tuzil@valueoutcomes.cz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two arms - the sulodexide arm compared to placebo arm

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: November 25, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CZ (19)