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LivRelief Varicose Veins Cream in the Treatment of Varicose Veins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653793
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Delivra, Inc.

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.

Condition or disease Intervention/treatment Phase
Varicose Veins Other: Natural Health Product: LivRelief Varicose Veins Cream Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LivRelief Varicose Veins Cream in the Treatment of Chronic Venous Insufficiency of the Lower Limbs: A 6-week Single Arm Pilot Study
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Experimental: LivRelief Varicose Veins Cream

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
This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.
Other Name: Natural Product Number (NPN) 80029349




Primary Outcome Measures :
  1. Recruitment feasibility [ Time Frame: study duration:~4 weeks ]
    Recruitment of at least 70% of all eligible participants

  2. Data Collection [ Time Frame: study duration: ~6 to 12 weeks ]
    Collection of at least 70% of scheduled data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653793


Locations
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Canada, Ontario
The Mayer Institute
Hamilton, Ontario, Canada, L8R 2R3
Sponsors and Collaborators
Delivra, Inc.
Investigators
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Principal Investigator: Perry V Mayer, MD The Mayer Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Delivra, Inc.
ClinicalTrials.gov Identifier: NCT03653793    
Other Study ID Numbers: Pro00020990
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases