Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
Not provided
Not provided
Not provided
This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.
This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). The study will include 21-45 participants randomly given active product or inactive product (placebo). Two (2) out of every three (3) participants enrolled will receive active product. The participants will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks |
|
| Placebo | Placebo Comparator | Cornstarch, one (1) capsule, two (2) times per day for eight (8) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diosmin | Combination Product | A medical food of diosmin and alka4-complex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Number (%) of healed baseline ulcers | Number (%) of healed baseline ulcers and change in net ulcer burden | Screening, Day 1, Day 28, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - number of adverse events | The number of product related adverse events experienced | Screening, Day 1, Day 28, Day 56 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukban | Contact | (480) 483-1410 | jlukban@primusrx.com | |
| Mary L Sanstead | Contact | 480-250-6689 | msanstead@primusrx.com |
| Name | Affiliation | Role |
|---|---|---|
| Lukban | Primus Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 1N4 | Canada |
all IPD that underlie results in a publication
starting 6 months after publication
Primus director of clinical research will review requests submitted via email.
Not provided
Not provided
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| C000721267 | digital ulcers |
| D012598 | Sclerosis |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D004145 | Diosmin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
Not provided
Not provided
This is a parallel study of two (2) arms in which participants receive different interventions. Participants are randomized and assigned to the treatment or placebo arm at the beginning of the trial. They continue in that arm throughout the length of the trial.
Not provided
Not provided
All subjects de-identified, all study staff blinded, all product labeled with number assignment, randomization performed by computer, number assignment conveyed to blinded study staff via computer.
| Placebo | Other | Corn starch one (1) capsule twice daily |
|
| Dalhousie University | Not yet recruiting | Halifax | Nova Scotia | B3H 4K4 | Canada |
|
| Saint Joseph Health Care Centre | Recruiting | London | Ontario | N6A 4V2 | Canada |
|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 7W9 | Canada |
|
| Mount Sinai Health System | Recruiting | Toronto | Ontario | M5T 3L9 | Canada |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |