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| Name | Class |
|---|---|
| TR Therapeutics | INDUSTRY |
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The safety and efficacy of beta glucan products, and specifically TR 987, in the treatment of chronic venous insufficiency ulcers has been established. This study is designed to determine the most efficient method of treatment.
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the effectiveness of TR 987 gel. It is a two-arm, design: One group will receive twice-weekly applications of 0.1% TR 987 in a gel base plus SoC for the first 4 weeks. The other group will receive twice-weekly applications of placebo gel base plus SoC for the same period of time. After 4 weeks, both groups will receive once weekly applications of their assigned treatment for the remaining 8 weeks of the trial. The Standard of Care therapy in this study is multi-layer compression therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR987 | Active Comparator | This group will receive twice-weekly applications of 0.1% TR 987 in a gel base plus SoC for the first 4 weeks, then once weekly applications for the remaining 8 weeks of the trial. |
|
| Placebo | Placebo Comparator | This group will receive twice-weekly applications of placebo gel base plus SoC for the first 4 weeks, then once weekly applications for the remaining 8 weeks of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% TR 987 | Drug | TR 987 0.1% |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Time to complete wound closure | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with complete ulcer healing | 12 weeks | |
| Change in ulcer size | 4 weeks | |
| Change in ulcer size |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Serena, MD | SerenaGroup, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Hope Podiatry Clinic | Los Angeles | California | 90063 | United States | ||
| Barry University Clinical Research |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 3, 2023 | |
| Reset | Sep 29, 2023 |
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| Placebo gel |
| Drug |
Placebo gel twice weekly for 4 weeks, then once weekly for 8 weeks. Gel will be applied to cover the wound cavity and wound surface to a thickness of 5 mm. |
|
| 12 weeks |
| Incidence of adverse events | 12 weeks |
| North Miami Beach |
| Florida |
| 33169 |
| United States |
| Royal Research Corp | Pembroke Pines | Florida | 33027 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Cleveland Foot and Ankle Clinic | Cleveland | Ohio | 44103 | United States |
| The Foot and Ankle Wellness Center | Ford City | Pennsylvania | 16226 | United States |
| Armstrong County Memorial Hospital | Kittanning | Pennsylvania | 16201 | United States |
| SerenaGroup Research Institute | Pittsburgh | Pennsylvania | 15222 | United States |
| Martin Foot and Ankle | York | Pennsylvania | 17402 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 3, 2023 | Sep 29, 2023 | |||
| Apr 7, 2024 | May 2, 2024 | 5 |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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