Clinical trial NCT03653793: LivRelief Varicose Veins Cream in the Treatment of Varicose Veins
Official title: LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Delivra, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This was a single arm pilot study to determine the feasibility of conducting an appropriately sized RCT within the same population using the same clinical outcome measures.

Eligible adult patients of the clinic with varicose veins were asked to use the cream as directed on the packaging for 6-weeks and the post-treatment measures were compared to baseline data. This study also provided SDs of the sample for comparison to the study population.
Primary purpose: TREATMENT

Brief summary: Phase IV interventional design where all participants used the test product as per package instructions for 6-weeks. Baseline observations were compared to those collected after 6-weeks of treatment.

Detailed description: The use of the marketed natural product, LivRelief Varicose Veins Cream, was observed in 32 patients with lower limb varicose veins. Participants were recruited from the patient population at The Mayer Institute in Hamilton Ontario, Canada. Patients that agreed to participate in the study and met the eligibility criteria were provided with a 6-week supply of the cream to use at home as directed on the product packaging. The following study measures were performed at the clinic prior to the first use of the cream, then again at the clinic after 6 weeks of use: CEAP (Clinical, Etiological, Anatomical, Pathophysiological) classification and VCSS (Venous Clinical Severity score). These are assessments performed by the doctor or nurse to determine the severity of their varicose veins and CVI (chronic venous insufficiency), measurements taken of the circumference of their legs to measure swelling of the legs, photographs of the varicose veins, a quality of life enjoyment and satisfaction questionnaire (QLES-Q-SF) completed by the subjects to describe their satisfaction with various aspects of their life over the last week and documentation of any reactions to the treatment. The cream was applied to their varicose veins twice a day for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* At least 19 years of age.
* Presence of lower limb varicose veins.

Exclusion Criteria:

* Allergy to witch-hazel or any allergies in the cream.
* Intent to undergo surgical treatment varicose veins within the next six weeks.
* Pregnant or breastfeeding or planning to be pregnant.
* Any Dementia or Major Cognitive dysfunction that would preclude the individual's ability to provide informed consent or complete the Case Report Form.
* Any unstable medical condition (including but not limited to cardiovascular, cardiac/hypertension disease, moderate to severe kidney disease, and moderate to severe liver disease)
* Any medical condition that would preclude the participant's or a caregiver's ability to administer the product on a daily basis for the time period required to complete the study.
* An active ulcer at the site of product application (as evaluated during CEAP screening).

Primary outcomes:
measure: Recruitment feasibility
timeFrame: study duration:~4 weeks
measure: Data Collection
timeFrame: study duration: ~6 to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: The Mayer Institute
state: Ontario
Study officials:
affiliation: The Mayer Institute
name: Perry V Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dwyer HC, Baranowski DC, Mayer PV, Gabriele S. LivRelief varicose veins cream in the treatment of chronic venous insufficiency of the lower limbs: A 6-week single arm pilot study. PLoS One. 2018 Dec 31;13(12):e0208954. doi: 10.1371/journal.pone.0208954. eCollection 2018.