LivRelief Varicose Veins Cream in the Treatment of Varicose Veins

Varicose Veins Clinical Trial

Official title:

LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653793
• Other study ID #: Pro00020990
• Status: Completed
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: August 28, 2017

Study information

• Verified date: August 2018
• Source: Delivra, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Other:
• Natural Health Product: LivRelief Varicose Veins Cream
This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.

Locations

Country	Name	City	State
Canada	The Mayer Institute	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Delivra, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment feasibility	Recruitment of at least 70% of all eligible participants	study duration:~4 weeks
Primary	Data Collection	Collection of at least 70% of scheduled data	study duration: ~6 to 12 weeks