LivRelief varicose veins cream in the treatment of chronic venous insufficiency of the lower limbs: A 6-week single arm pilot study

Abstract

Background: Chronic Venous Disease is characterized by morphological abnormalities of the venous system. Affected limbs are classified in increasing clinical severity with the Clinical Etiological Anatomical and Pathological system from C0 to C6. Limbs assessed at C3 through C6 meet the criteria of Chronic Venous Insufficiency. Chronic Venous Insufficiency of the Lower Limbs is a very common pathology affecting approximately ~40% of the world's population. This study observes the use of the LivRelief Varicose Vein Cream, a Natural Health Product that is licensed for sale by Health Canada, for use in the treatment of varicose veins.

Methods: An open label, single arm interventional, pilot study was conducted to determine the feasibility of recruitment and data collection in this population. To accomplish this, the cream was provided to all enrolled subjects. Subsequently, objective and subjective measures were performed at baseline and after 6 weeks of at-home use. Recruitment and data collection targets of at least 70% were established and the data collected at both timepoints were compared and analyzed using a paired t-test. Results were also reported as proportions where appropriate.

Results: A total of 32 subjects were enrolled. The pre-defined feasibility objectives for recruitment and data collection were met with the enrolment of 97% of all screened patients and the collection of 94% of all scheduled data. The most significant therapeutic improvement was seen in the results of the Venous Clinical Severity Score where 66% of the treated legs experienced a decrease in severity after 6 weeks of treatment. P values were <0.0001 and 0.0003 for the left and right leg, respectively.

Conclusion: It is feasible to recruit and collect data with the chosen outcome assessments within this population. Preliminary results suggest that the product could improve some of the clinical symptoms associated with the presence varicose veins. These results warrant further exploration in a longer, randomized and placebo-controlled study.

Trial registration: Clinicaltrial.gov: NCT03653793.

Conflict of interest statement

The authors are/were employees of Delivra Corp. This commercial affiliation does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials. The protocol was reviewed by an independent ethics committee and conducted under the supervision of the PI. Data was collected by the investigator’s research team in compliance with privacy laws and GCP. The case report forms were reviewed by the PI prior to database lock and export for analysis. The principal investigator (2nd author) has no conflict of interest to declare.

Figures

Fig 1. Study plan and subject accountability.

Fig 2. VCSS Scores before and after 6 weeks of treatment with the LivRelief varicose veins cream.

**Mean Change in VCSS score of Left Leg between visits: P = <0.0001. *Mean Change in VCSS score of Right Leg between visits: P = 0.0003. Statistical analysis was completed using a paired t-test.

Fig 3. Q-LES-Q-SF Scores before and after 6 weeks of treatment with the LivRelief varicose veins cream.

Fig 4. CEAP Classification before and after 6 weeks of treatment with the LivRelief varicose veins cream.

Fig 5. Mid-foot circumference before and after 6 weeks of treatment with the LivRelief varicose veins cream.

Mean Change in Mid-Foot Circumference between visits 1 & 2 were analyzed using a paired t-test with P = 0.0017 and 0.0246 for the *Left and **Right legs respectively.