Lipedema
Conditions
Brief summary
This study is designed to gain preliminary information via a uniform protocol regarding the clinical effects of Vasculera in participants with lipedema and the possible role of the glycocalyx as a physiological target for Vasculera activity. It is anticipated that the results of this case study will inform the development of a formal randomized, double-blind, placebo controlled trial.
Detailed description
The goal of this type of clinical trial is to compare the measurement of participants legs before treatment and after using the treatment for approximately 3 months in clinic patients 20 to 70 years old with lipedema. The main questions it aims to answer are: does the leg circumference decrease and does the participants' overall wellbeing improve? Participants will: * Have physical examinations and measurements at baseline and 3 month visit * Complete wellbeing self-assessments at baseline and 3 month visit * Have blood drawn for chemical markers at baseline and 3 month visit * Complete four visits total
Interventions
DIETARY_SUPPLEMENTDiosmiplex
diosmin glycoside in combination with alkaline granules known as alka4-complex
Sponsors
Northeastern University
Primus Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
three (3) month open-label case study
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. established diagnosis of lipedema for at least one (1) year 2. women, ages 20 to 70 years 3. score of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well being 4. be willing to stop compression therapy for one week prior to each visit
Exclusion criteria
1. other forms of leg enlargement, including lymphedema 2. any primary systemic vasculopathy 3. history of exposure to Vasculera or other diosmin containing medication within one (1) year of the screening visit 4. concomitant use of warfarin, platelet inhibitors, factor Xa inhibitors or any medication intended to reduce blood coagulability 5. concomitant use of diclofenac, metronidazole or chlorzoxazone 6. uncontrolled hypertension (BP\>170/110), unstable cardiac disease, active skin ulceration 7. any other disease or condition that, in the opinion of the investigator, might put the 8. subject at risk by participation in this study OR confound evaluation of response to Vasculera 9. history of substance abuse within one (1) year of the screening visit or of current alcohol consumption more than one (1) unit daily. For purposes of this study, a unit of alcohol will be considered to be 12 oz of beer, 6 oz of wine or 1 oz of hard spirits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight From Baseline | Visit 4 (3 months) | Weight in kilograms on digital, calibrated bathroom scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI From Baseline | Visit 4 (3 months) | BMI in kilograms per meter squared |
| Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline | Visit 4 (3 months) | 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 |
| Change in Right Leg Discomfort From Baseline | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Change in Left Leg Discomfort From Baseline | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Change in Right Leg Feeling of Swelling or Tightness From Baseline | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Change in Left Leg Feeling of Swelling or Tightness From Baseline | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Change in Right Leg Tenderness From Baseline | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Change in Left Leg Tenderness From Baseline | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Change in Right Leg Bruising From Baseline | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Percentage Change Right Leg at 2 Inches | Visit 4 (3 month) | Right leg circumference measured at 2 inches above the right lateral malleoli |
| Change in Right Leg Redness | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Change in Left Leg Redness | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
| Change in Fatigue | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt |
| Change in Ability to Perform Activities of Daily Living | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt |
| Change in the Overall Sense of Wellbeing | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt |
| Investigator Assessment of Response to Therapy | Visit 4 (3 months) | Likert scale from 0 to 5 where 0 is no response and 5 is the best response |
| Percentage Change Right Leg at 12 Inches | Visit 4 (3 month) | Right leg circumference measured at 12 inches above the right lateral malleoli |
| Percentage Change Left Leg at 2 Inches | Visit 4 (3 month) | Left leg circumference measured at 2 inches above the left lateral malleoli |
| Percentage Change Left Leg at 12 Inches | Visit 4 (3 month) | Left leg circumference measured at 12 inches above the left lateral malleoli |
| Change in Left Leg Bruising From Baseline | Visit 4 (3 months) | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of 34 participants recruited from site medical records, 34 met inclusion criteria and progressed to open-label treatment.
Participants by arm
| Arm | Count |
|---|---|
| Vasculera Vasculera 630 milligrams, one tablet two times per day
Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Vasculera |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Race/Ethnicity, Customized Race African American | 7 Participants |
| Race/Ethnicity, Customized Race White | 27 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 102.54 Kilograms STANDARD_DEVIATION 22.86 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Change in Weight From Baseline
Weight in kilograms on digital, calibrated bathroom scale
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Weight From Baseline | 0.340 kilograms | Standard Error 0.468 |
p-value: 0.473ANCOVA
Secondary
Change in Ability to Perform Activities of Daily Living
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Ability to Perform Activities of Daily Living | -2.88 score on a scale | Standard Error 0.4 |
p-value: <0.001ANCOVA
Secondary
Change in BMI From Baseline
BMI in kilograms per meter squared
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in BMI From Baseline | 0.14 kilograms per meter squared | Standard Error 0.17 |
p-value: 0.408ANCOVA
Secondary
Change in Fatigue
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Fatigue | -3.06 score on a scale | Standard Error 0.4 |
p-value: <0.001ANCOVA
Secondary
Change in Left Leg Bruising From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Left Leg Bruising From Baseline | -3.26 score on a scale | Standard Error 0.48 |
p-value: <0.001ANCOVA
Secondary
Change in Left Leg Discomfort From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Left Leg Discomfort From Baseline | -2.62 score on a scale | Standard Error 0.37 |
p-value: <0.001ANCOVA
Secondary
Change in Left Leg Feeling of Swelling or Tightness From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Left Leg Feeling of Swelling or Tightness From Baseline | -2.56 score on a scale | Standard Error 0.47 |
p-value: <0.001ANCOVA
Secondary
Change in Left Leg Redness
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Left Leg Redness | -1.85 score on a scale | Standard Error 0.41 |
p-value: <0.001ANCOVA
Secondary
Change in Left Leg Tenderness From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Left Leg Tenderness From Baseline | -2.71 score on a scale | Standard Error 0.48 |
p-value: <0.001ANCOVA
Secondary
Change in Right Leg Bruising From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Right Leg Bruising From Baseline | -3.44 score on a scale | Standard Error 0.49 |
p-value: <0.001ANCOVA
Secondary
Change in Right Leg Discomfort From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Right Leg Discomfort From Baseline | -2.53 score on a scale | Standard Error 0.39 |
p-value: <0.001ANCOVA
Secondary
Change in Right Leg Feeling of Swelling or Tightness From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Right Leg Feeling of Swelling or Tightness From Baseline | -2.65 score on a scale | Standard Error 0.41 |
p-value: <0.001ANCOVA
Secondary
Change in Right Leg Redness
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Right Leg Redness | -1.79 score on a scale | Standard Error 0.422 |
p-value: <0.001ANCOVA
Secondary
Change in Right Leg Tenderness From Baseline
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Right Leg Tenderness From Baseline | -2.77 score on a scale | Standard Error 0.46 |
p-value: <0.001ANCOVA
Secondary
Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline
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
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline | -7.12 score on a scale | Standard Error 0.94 |
p-value: <0.001ANCOVA
Secondary
Change in the Overall Sense of Wellbeing
An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Change in the Overall Sense of Wellbeing | -2.47 score on a scale | Standard Error 0.44 |
p-value: <0.001ANCOVA
Secondary
Investigator Assessment of Response to Therapy
Likert scale from 0 to 5 where 0 is no response and 5 is the best response
Time frame: Visit 4 (3 months)
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Investigator Assessment of Response to Therapy | 3.29 score on a scale | Standard Error 0.22 |
Secondary
Percentage Change Left Leg at 12 Inches
Left leg circumference measured at 12 inches above the left lateral malleoli
Time frame: Visit 4 (3 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Percentage Change Left Leg at 12 Inches | 1.92 percentage of change | Standard Deviation 2.74 |
p-value: 0.00849paired t-test
Secondary
Percentage Change Left Leg at 2 Inches
Left leg circumference measured at 2 inches above the left lateral malleoli
Time frame: Visit 4 (3 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Percentage Change Left Leg at 2 Inches | 0.73 percentage of change | Standard Deviation 2.48 |
p-value: 0.23077paired t-test
Secondary
Percentage Change Right Leg at 12 Inches
Right leg circumference measured at 12 inches above the right lateral malleoli
Time frame: Visit 4 (3 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Percentage Change Right Leg at 12 Inches | -2.13 percentage of change | Standard Deviation 2.78 |
p-value: 0.00463paired t-test
Secondary
Percentage Change Right Leg at 2 Inches
Right leg circumference measured at 2 inches above the right lateral malleoli
Time frame: Visit 4 (3 month)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vasculera | Percentage Change Right Leg at 2 Inches | -0.79 percentage of change | Standard Deviation 1.44 |
p-value: 0.03199paired t-test