Actively Recruiting
A Phase 3 Randomized, Double-Blind Study of TR987 0.1% Gel Plus Standard of Care Versus Standard of Care Alone for Chronic Venous Leg Ulcers
Led by TR Therapeutics · Updated on 2026-02-12
312
Participants Needed
33
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether TR987 0.1% gel combined with Standard of Care is more effective than Standard of Care alone for treating Venous Leg Ulcers (VLUs). This Phase 3, outpatient, randomized, double-blind study focuses on participants with non-healing VLUs to assess the drug's efficacy and safety over 16 weeks. Participants are assigned to one of two groups: one receiving TR987 0.1% gel plus Standard of Care, and the other receiving Standard of Care alone. The gel is applied topically twice weekly for the first four weeks, then weekly for the remaining 12 weeks. Standard of Care includes wound cleansing, dressings, and compression bandaging throughout the treatment period. During the study, participants will be regularly assessed for ulcer closure, pain levels, and changes in ulcer size at 12 and 16 weeks. The primary measure is the proportion of participants with complete ulcer closure by Week 16. Secondary outcomes include sustained closure at 3 months, pain reduction, and significant ulcer size reduction. Safety and tolerability are also monitored throughout the study period.
CONDITIONS
Brief Title
Tissue Repair Gel in Venous Leg Ulcers (US)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older
- Clinically diagnosed and medically confirmed venous insufficiency
- Females must not be pregnant or breastfeeding and use acceptable birth control if of child-bearing potential
- Venous ulcer size between 2 cm2 and 12 cm2 at randomization
- Target ulcer age of at least 4 weeks at screening
- Adequate arterial blood flow confirmed by ABI/TBI, TB, SPP, TCPo2, or Duplex Doppler
- Body mass index (BMI) of 50 kg/m2 or less
- HbA1C level of 12% or less
You will not qualify if you...
- Target ulcer treated with prohibited medications or therapies
- History of radiation at the target ulcer site
- Target ulcer decreased in area by 30% or more during screening period
- History of osteomyelitis at the target ulcer within 6 months before screening
- Participants considered nutritionally deficient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive TR987 0.1% gel plus standard wound care or standard care alone for their venous leg ulcers.
Twice weekly visits for the first 4 weeks, then weekly visits for the remaining 12 weeks
Duration - 3 months after treatment
Participants are followed for 3 months after treatment to assess ulcer closure and maintenance.
1 follow-up visit (in-person)
Trial Site Locations
Total: 33 locations
1
Clincial Research Site 21
Tucson, Arizona, United States, 85715
Active, Not Recruiting
2
Clincial Research Site 43C
Castro Valley, California, United States, 94546
Actively Recruiting
3
Clincial Research Site 14
Fresno, California, United States, 93710
Actively Recruiting
4
Clincial Research Site 11
Los Angeles, California, United States, 90063
Actively Recruiting
5
Clincial Research Site 43A
San Francisco, California, United States, 94115
Actively Recruiting
6
Clincial Research Site 43B
San Francisco, California, United States, 94117
Actively Recruiting
7
Clincial Research Site 54
Vista, California, United States, 92081
Actively Recruiting
8
Clincial Research Site 47
Deerfield Beach, Florida, United States, 33442
Active, Not Recruiting
9
Clincial Research Site 38
Hollywood, Florida, United States, 33021
Not Yet Recruiting
10
Clincial Research Site 40
Jacksonville, Florida, United States, 32209
Actively Recruiting
11
Clincial Research Site 19
Miami, Florida, United States, 33150
Actively Recruiting
12
Clincial Research Site 26
Miami, Florida, United States, 33156
Actively Recruiting
13
Clincial Research Site 13
Pembrook Pines, Florida, United States, 33026
Actively Recruiting
14
Clincial Research Site 51
Tamarac, Florida, United States, 33321
Withdrawn
15
Clincial Research Site 22
Chicago, Illinois, United States, 60611
Not Yet Recruiting
16
Clincial Research Site 34
Chicago, Illinois, United States, 60649
Actively Recruiting
17
Clincial Research Site 10
O'Fallon, Illinois, United States, 62269
Actively Recruiting
18
Clincial Research Site 49
Springfield, Illinois, United States, 62704
Actively Recruiting
19
Clincial Research Site 04
Bossier City, Louisiana, United States, 71111
Actively Recruiting
20
Clincial Research Site 01
Lafayette, Louisiana, United States, 70507
Actively Recruiting
21
Clincial Research Site 07
D'Iberville, Mississippi, United States, 39540
Actively Recruiting
22
Clincial Research Site 02
McComb, Mississippi, United States, 39648
Actively Recruiting
23
Clincial Research Site 30
New York, New York, United States, 10019
Actively Recruiting
24
Clincial Research Site 37
Syosset, New York, United States, 11791
Actively Recruiting
25
Clincial Research Site 55
Winston-Salem, North Carolina, United States, 27157
Active, Not Recruiting
26
Clincial Research Site 45
Grove City, Ohio, United States, 43123
Withdrawn
27
Clincial Research Site 23
Mentor, Ohio, United States, 44060
Withdrawn
28
Clincial Research Site 28
Tulsa, Oklahoma, United States, 74137
Actively Recruiting
29
Clincial Research Site 36
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
30
Clincial Research Site 24
Fort Worth, Texas, United States, 76104
Actively Recruiting
31
Clincial Research Site 32
Houston, Texas, United States, 27707
Actively Recruiting
32
Clincial Research Site 46
San Antonio, Texas, United States, 78224
Not Yet Recruiting
33
Clincial Research Site 18
Suffolk, Virginia, United States, 23434
Actively Recruiting
Research Team
A
Anhthu Nguyen Vice President, Global Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here