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| Name | Class |
|---|---|
| Northeastern University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasculera | Other | Vasculera 630 milligrams, two times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diosmiplex | Dietary Supplement | diosmin glycoside in combination with alkaline granules known as alka4-complex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight From Baseline | Weight in kilograms on digital, calibrated bathroom scale | Visit 4 (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change Right Leg at 2 Inches | Right leg circumference measured at 2 inches above the right lateral malleoli | Visit 4 (3 month) |
| Change in BMI From Baseline | BMI in kilograms per meter squared |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Levy, MD | Primus Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primus Pharmaceuticals | Scottsdale | Arizona | 85251 | United States |
Article written by investigator Response to all queries
120 days from NCT assignment
Access will be given when requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal.
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Of 34 participants recruited from site medical records, 34 met inclusion criteria and progressed to open-label treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vasculera | Vasculera 630 milligrams, two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vasculera | Vasculera 630 milligrams, one tablet two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age was calculated from birthdate to informed consent |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight From Baseline | Weight in kilograms on digital, calibrated bathroom scale | Intent to treat | Posted | Mean | Standard Error | kilograms | Visit 4 (3 months) |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vasculera | Vasculera 630 milligrams, two times per day Diosmiplex: diosmin glycoside in combination with alkaline granules known as alka4-complex |
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For 16 participants, the Change from Baseline could not be calculated as the Baseline measurement was incorrectly measured at 2 centimeters and 12 centimeters above the lateral maleoli and not 2 inches and 12 inches above the lateral maleoli per protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Primus Pharmaceuticals, Inc. | 480-483-1410 | info@primusrx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2019 | May 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2019 | May 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065134 | Lipedema |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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three (3) month open-label case study
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| Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| Change in Right Leg Redness | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt | Visit 4 (3 months) |
| Change in Left Leg Redness | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt | Visit 4 (3 months) |
| Change in Fatigue | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt | Visit 4 (3 months) |
| 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 | Visit 4 (3 months) |
| Change in the Overall Sense of Wellbeing | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt | Visit 4 (3 months) |
| Investigator Assessment of Response to Therapy | Likert scale from 0 to 5 where 0 is no response and 5 is the best response | Visit 4 (3 months) |
| Percentage Change Right Leg at 12 Inches | Right leg circumference measured at 12 inches above the right lateral malleoli | Visit 4 (3 month) |
| Percentage Change Left Leg at 2 Inches | Left leg circumference measured at 2 inches above the left lateral malleoli | Visit 4 (3 month) |
| Percentage Change Left Leg at 12 Inches | Left leg circumference measured at 12 inches above the left lateral malleoli | Visit 4 (3 month) |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | participant interview | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
|
|
| Secondary | Percentage Change Right Leg at 2 Inches | Right leg circumference measured at 2 inches above the right lateral malleoli | Posted | Mean | Standard Deviation | percentage of change | Visit 4 (3 month) |
|
|
|
|
| Secondary | Change in BMI From Baseline | BMI in kilograms per meter squared | Intent to treat | Posted | Mean | Standard Error | kilograms per meter squared | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| Secondary | Change in Right Leg Redness | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| Secondary | Change in Left Leg Redness | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever seen or felt | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| Secondary | Change in Fatigue | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| 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 | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| Secondary | Change in the Overall Sense of Wellbeing | An integer scale from 0 - 10 where 0 equals none and 10 equals worst ever felt | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
|
| Secondary | Investigator Assessment of Response to Therapy | Likert scale from 0 to 5 where 0 is no response and 5 is the best response | Intent to treat | Posted | Mean | Standard Error | score on a scale | Visit 4 (3 months) |
|
|
|
| Secondary | Percentage Change Right Leg at 12 Inches | Right leg circumference measured at 12 inches above the right lateral malleoli | Posted | Mean | Standard Deviation | percentage of change | Visit 4 (3 month) |
|
|
|
|
| Secondary | Percentage Change Left Leg at 2 Inches | Left leg circumference measured at 2 inches above the left lateral malleoli | Posted | Mean | Standard Deviation | percentage of change | Visit 4 (3 month) |
|
|
|
|
| Secondary | Percentage Change Left Leg at 12 Inches | Left leg circumference measured at 12 inches above the left lateral malleoli | Posted | Mean | Standard Deviation | percentage of change | Visit 4 (3 month) |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
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