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The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs). It will also provide additional information about the safety of drug TR987 0.1% gel.
This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU).
The primary objective is to assess the proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit.
Secondary endpoints include: • Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint). • Change from baseline in participant's perception of pain level at 12 weeks. • Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint. • Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit. • Proportion of participants with any significant reduction in pain at or before 12 weeks. There are also some supplementary and safety endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR987 0.1% gel + Standard of Care | Experimental | Participants will receive up to 16 weeks of TR987 0.1% gel topically + Standard of Care (wound cleansing/dressings and compression bandaging). Treatment will be twice weekly for the first four weeks then weekly for the remaining 12 weeks. |
|
| Standard of Care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR987 0.1% gel + Standard of Care | Drug | 6mg topical gel for application plus Standard of Care (wound cleansing/dressings and compression bandaging) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with Complete Closure of the target ulcer at or before the Week-16 end of treatment (EOT) visit. | Patient count | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with Complete Closure of the target ulcer at or before the Week 16 visit AND for whom the ulcer remains closed at the 3-Month Follow-Up visit after such closure (a composite endpoint) | Patient count | 16 weeks |
| Change from baseline in participant's perception of pain level at 12 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anhthu Nguyen Vice President, Global Clinical Operations | Contact | (+61) 280 034 554 | anhthu.nguyen@trtherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clincial Research Site 21 | Active, not recruiting | Tucson | Arizona | 85715 | United States | |
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| Label | URL |
|---|---|
| Related Info | View source |
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If the clinical data will be published, the relevant information may be made available.
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This is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: TR987 0.1% gel + Standard of Care and Standard of Care alone in participants who have a non-healing Venous Leg Ulcer (VLU)
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Participants will be randomized to either TR987 1% gel + Standard of Care and Standard of Care alone. Sponsor, participant, and Investigator/Outcomes Assessor will be masked throughout the treatment period.
| Standard of care | Other | Standard of Care (wound cleansing/dressings and compression bandaging) |
|
Pain to be measured on a 10 point numeric rating scale |
| 12 weeks |
| Percent change from baseline in the target ulcer area at 12 and 16 weeks. In the event of Complete Closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint. | Measure the are of the wound in cm2 at baseline and at 12 and 16 weeks and calculate the percentage change | 12 and 16 weeks |
| Proportion of participants with Complete Closure of the target ulcer at or before the Week 12 treatment visit. | Count the number of patients with complete closure and divide by the total number of patients | 12 weeks |
| Proportion of participants with any significant reduction in pain at or before 12 weeks. | Count the number of patients with any significant reduction in pain and divide by the total number of patients | 12 weeks |
| Proportion of target ulcers which reach greater than 70% closure at 12 weeks and 16 weeks | Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis) | 12 and 16 weeks |
| Proportion of target ulcers which reach greater than 90% closure at 12 weeks and 16 weeks | Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis) | 12 and 16 weeks |
| Proportion of target ulcers which reach greater than 95% closure at 12 weeks and 16 weeks | Measured by MolecuLight® versus baseline area at TV1 after therapeutic debridement (Complete Closure at a time point before 12 or 16 weeks shall be deemed to be >70% closed at 12 or 16-weeks, respectively, for purposes of this analysis) | 12 and 16 weeks |
| Clincial Research Site 43C |
| Recruiting |
| Castro Valley |
| California |
| 94546 |
| United States |
|
| Clincial Research Site 14 | Recruiting | Fresno | California | 93710 | United States |
|
| Clincial Research Site 11 | Recruiting | Los Angeles | California | 90063 | United States |
|
| Clincial Research Site 43A | Recruiting | San Francisco | California | 94115 | United States |
|
| Clincial Research Site 43B | Recruiting | San Francisco | California | 94117 | United States |
|
| Clincial Research Site 54 | Recruiting | Vista | California | 92081 | United States |
|
| Clincial Research Site 47 | Active, not recruiting | Deerfield Beach | Florida | 33442 | United States |
| Clincial Research Site 38 | Not yet recruiting | Hollywood | Florida | 33021 | United States |
|
| Clincial Research Site 40 | Recruiting | Jacksonville | Florida | 32209 | United States |
|
| Clincial Research Site 19 | Recruiting | Miami | Florida | 33150 | United States |
|
| Clincial Research Site 26 | Recruiting | Miami | Florida | 33156 | United States |
|
| Clincial Research Site 13 | Recruiting | Pembrook Pines | Florida | 33026 | United States |
|
| Clincial Research Site 51 | Withdrawn | Tamarac | Florida | 33321 | United States |
| Clincial Research Site 22 | Not yet recruiting | Chicago | Illinois | 60611 | United States |
| Clincial Research Site 34 | Recruiting | Chicago | Illinois | 60649 | United States |
|
| Clincial Research Site 10 | Recruiting | O'Fallon | Illinois | 62269 | United States |
|
| Clincial Research Site 49 | Recruiting | Springfield | Illinois | 62704 | United States |
|
| Clincial Research Site 04 | Recruiting | Bossier City | Louisiana | 71111 | United States |
|
| Clincial Research Site 01 | Recruiting | Lafayette | Louisiana | 70507 | United States |
|
| Clincial Research Site 07 | Recruiting | D'Iberville | Mississippi | 39540 | United States |
|
| Clincial Research Site 02 | Recruiting | McComb | Mississippi | 39648 | United States |
|
| Clincial Research Site 30 | Recruiting | New York | New York | 10019 | United States |
|
| Clincial Research Site 37 | Recruiting | Syosset | New York | 11791 | United States |
|
| Clincial Research Site 55 | Active, not recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Clincial Research Site 45 | Withdrawn | Grove City | Ohio | 43123 | United States |
| Clincial Research Site 23 | Withdrawn | Mentor | Ohio | 44060 | United States |
| Clincial Research Site 28 | Recruiting | Tulsa | Oklahoma | 74137 | United States |
|
| Clincial Research Site 36 | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Clincial Research Site 24 | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Clincial Research Site 32 | Recruiting | Houston | Texas | 27707 | United States |
|
| Clincial Research Site 46 | Not yet recruiting | San Antonio | Texas | 78224 | United States |
|
| Clincial Research Site 18 | Recruiting | Suffolk | Virginia | 23434 | United States |
|
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014947 | Wounds and Injuries |
| 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 |
|---|---|
| D005782 | Gels |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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