Tissue Repair Gel in Venous Leg Ulcers in AU/US
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Adults 18 years and older
- Venous insufficiency has been clinically diagnosed clinically and medically confirmed.
- Females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control.
- The Venous Ulcer should be between 2 cm2 and 12 cm2 at randomization.
- Target ulcer age must be ≥ 4 weeks at Screening.
- Participants must have adequate arterial flow as confirmed by ABI/TBI, TB, SPP, TCPo2, or Duplex Doppler.
- Body mass index (BMI) ≤ 50 kg/m2.
- HbA1C ≤12%
Exclusion criteria
- Target ulcer has been treated with prohibited medications or therapies.
- History of radiation at the target ulcer site.
- Target ulcer decreases in area by 30% or more during screening period.
- History of osteomyelitis at the target ulcer within 6 months of screening.
- History of cancer in the preceding 5 years (except as noted in the protocol).
- Participants considered nutritionally deficient.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: FEMALE
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06707103
Intervention or treatment
DRUG: TR987 0.1% gel + Standard of Care
OTHER: Standard of care
Conditions
- Venous Leg Ulcer
- Venous Ulcer
- Venous Stasis Ulcer
- Venous Stasis
- Wound Heal
- Wound
- Venous Insufficiency of Leg
- Non-healing Wound
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Clincial Research Site 62
Select from list below to view details:
Clincial Research Site 62
Camperdown, New South Wales, Australia
Clinical Research Site 84
Kogarah, New South Wales, Australia
Clincial Research Site 78
Orange, New South Wales, Australia
Clincial Research Site 85
Sydney, New South Wales, Australia
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Who is running the clinical trial?
TR Therapeutics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: TR987 0.1% gel + Standard of Care
| Drug: TR987 0.1% gel + Standard of Care |
OTHER: Standard of Care
| Other: Standard of care |
What is the study measuring?
Primary Outcome
| 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 |
Secondary Outcome
| 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. | 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 |
References
Clinical Trials Gov: Tissue Repair Gel in Venous Leg Ulcers in AU/USOther trials to consider
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