Trial Outcomes & Findings for Vasculera in Participants With Lipedema (NCT NCT05616962)

Results Overview

Weight in kilograms on digital, calibrated bathroom scale

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Visit 4 (3 months)

Results posted on

2024-12-12

Participant Flow

Participants were recruited based on physician referral at 2 private medical offices between May 2019 and June 20219. The first participant first visit was May 26, 2019.

Of 34 participants recruited from site medical records, 34 met inclusion criteria and progressed to open-label treatment.

Participant milestones

Participant milestones
Measure	Vasculera Vasculera 630 milligrams, two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vasculera in Participants With Lipedema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vasculera n=34 Participants Vasculera 630 milligrams, one tablet two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	27 Participants n=5 Participants
Weight	102.54 Kilograms STANDARD_DEVIATION 22.86 • n=5 Participants

PRIMARY outcome

Timeframe: Visit 4 (3 months)

Population: Intent to treat

Weight in kilograms on digital, calibrated bathroom scale

Outcome measures

Outcome measures
Measure	Vasculera n=34 Participants Vasculera 630 milligrams, two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex
Change in Weight From Baseline	0.340 kilograms Standard Error 0.468

SECONDARY outcome

Timeframe: Visit 4 (3 month)

Right leg circumference measured at 2 inches above the right lateral malleoli

Outcome measures

Outcome measures
Measure	Vasculera n=18 Participants Vasculera 630 milligrams, two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex
Percentage Change Right Leg at 2 Inches	-0.79 percentage of change Standard Deviation 1.44

SECONDARY outcome

Timeframe: Visit 4 (3 months)

Population: Intent to treat

BMI in kilograms per meter squared

Outcome measures

Outcome measures
Measure	Vasculera n=34 Participants Vasculera 630 milligrams, two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex
Change in BMI From Baseline	0.14 kilograms per meter squared Standard Error 0.17

SECONDARY outcome

Timeframe: Visit 4 (3 months)

Population: Intent to treat

Short Western Ontario and McMaster Universities Osteoarthritis Index total score results calculated by summing the response to individual questions with range from 0 - 96 where 0 is the best score and 96 is the worst

Outcome measures

Outcome measures
Measure	Vasculera n=34 Participants Vasculera 630 milligrams, two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex
Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline	-7.12 score on a scale Standard Error 0.94