LivRelief Varicose Veins Cream in the Treatment of Varicose Veins

NCT03653793 | Completed

• 1 other identifier: Pro00020990
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (2)

• Recruitment feasibility

  Recruitment of at least 70% of all eligible participants

  study duration:~4 weeks

• Data Collection

  Collection of at least 70% of scheduled data

  study duration: ~6 to 12 weeks

Study Arms (1)

LivRelief Varicose Veins Cream

EXPERIMENTAL

Intervention: All subjects were provided with an adequate supply of the Natural Health Product LivRelief Varicose Veins cream for 6 weeks of at home use.

Other: Natural Health Product: LivRelief Varicose Veins Cream

Interventions

Natural Health Product: LivRelief Varicose Veins Cream OTHER

This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.

Also known as: Natural Product Number (NPN) 80029349

LivRelief Varicose Veins Cream

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Delivra, Inc.: lead

Study Sites (1)

The Mayer Institute

Hamilton, Ontario, L8R 2R3, Canada

Location

Related Publications (1)

• 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.

  PMID: 30596677 DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Perry V Mayer, MD

  The Mayer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: May 23, 2017
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)