Clinical trial NCT02191163: Efficacy of Antistax® in Improving Microcirculation of the Skin in the Leg in Patients Suffering From Chronic Venous Insufficiency
Official title: A 17 Week, Randomised, Double-blind, Placebo Controlled Cross-over Trial to Evaluate the Efficacy of Antistax® Film Coated Tablets (Extr. Vitis Vinifera Siccum), 360 mg/Day p.o. in Improving Microcirculation of the Skin in the Leg of Male and Female Patients Suffering From Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Insufficiency
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to determine the efficacy and safety of Antistax® film coated tablets in improving microcirculation of the skin in the leg of patients with chronic venous insufficiency (CVI)


Eligibility criteria: Inclusion Criteria:

* Male or female
* \>= 18 years of age
* CVI I or CVI II (without expanded trophic disturbances)
* Willing and able to give written informed consent in accordance to Good Clinical Practice and local legislation prior to participation in the study

Exclusion Criteria:

Concomitant disease(s) exclusion criteria:

* Decompensated cardiac insufficiency
* Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc)
* Peripheral arterial disease (ankle/arm pressure index \< 0.9)
* Current acute phlebitis or thrombosis
* Renal insufficiency (Serum creatinine \> 1.5 mg/dl)
* Liver disease (SGPT (ALAT) \> 3x upper limit of normal)
* Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies
* Anamnestic indications of diabetic microangiopathy or polyneuropathy
* Drug and/or alcohol abuse
* Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
* Severe climacteric complaints or changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months
* Immobility
* Avalvulie
* Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
* State after pulmonary embolism
* Recognized hypersensitivity to the trial drug ingredients
* Current florid venous ulcus
* Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.

Previous treatment(s) exclusion criteria:

* Treatment with venous drugs within the last 4 weeks
* Changes in, or initiation with, treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days

Concomitant treatment/non-drug therapy exclusion criteria:

* Other venous drugs apart from the trial medication
* Compression bandages
* Venous surgery of the leg used for the fluxmetry
* Extensive use (i.e. on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance
* Major surgery requiring full anesthesia

Other exclusion criteria:

* Previously studied under this protocol
* Participation in another clinical trial within the previous 90 days or during the present study
* Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial
* Patients in a bad general health state according to the investigator's judgment

Primary outcomes:
measure: Changes from baseline in the resting flux
timeFrame: Baseline, after 6 weeks of treatment
Secondary outcomes:
measure: Changes from baseline in the resting flux
timeFrame: Baseline, after 3 weeks of treatment
measure: Changes in the resting flux
timeFrame: Baseline, after 3 and 6 weeks of treatment
measure: Changes in the combined resting fluxes (<37 kHz)
timeFrame: Baseline, after 3 and 6 weeks of treatment
measure: Changes in the transcutaneous oximetry (TcPO2)
timeFrame: Baseline, after 3 and 6 weeks of treatment
measure: Change from baseline in the calf circumference of the most affected leg
timeFrame: Baseline, after 3 and 6 weeks of treatment
measure: Change from baseline in the ankle circumference of the most affected leg
timeFrame: Baseline, after 3 and 6 weeks of treatment
measure: Change from baseline in the subjective symptoms of CVI measured by Visual Analogue Scales (VAS)
timeFrame: Baseline, after 3 and 6 weeks of treatment
measure: Global efficacy assessment by patient on a 4-point verbal rating scale (VRS)
timeFrame: after 6 weeks of treatment
measure: Global efficacy assessment by investigator on a 4-point VRS
timeFrame: after 6 weeks of treatment
measure: Number of patients with adverse events
timeFrame: up to 16 weeks
measure: Number of patients with clinically relevant changes in laboratory values
timeFrame: Baseline, up to 16 weeks
measure: Number of patients with clinically significant changes in vital signs
timeFrame: Baseline, up to 16 weeks
measure: Global tolerability assessment by investigator on a 4-point VRS
timeFrame: after 6 weeks of treatment
measure: Global tolerability assessment by patient on a 4-point VRS
timeFrame: after 6 weeks of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.