Tissue Repair Gel in Venous Leg Ulcers in AU/US

Description

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.

Conditions

Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis, Wound Heal, Wound, Venous Insufficiency of Leg, Non-healing Wound

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Study Overview

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Study Details

Study overview

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.

A Phase 3 Randomized, Parallel Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, and Safety of TR987® 0.1% Gel Versus Standard of Care in the Treatment of Chronic Venous Insufficiency Leg Ulcers (VLU)

Tissue Repair Gel in Venous Leg Ulcers in AU/US

Condition
Venous Leg Ulcer
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Clincial Research Site 92, Jacksonville, Florida, United States, 32256

Clinton Twp

Clincial Research Site 77, Clinton Twp, Michigan, United States, 48038

Lake Success

Clincial Research Site 82, Lake Success, New York, United States, 11042

Fort Worth

Clinical Research Site 76, Fort Worth, Texas, United States, 76104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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, or TCPo2.
  • * Body mass index (BMI) ≤ 42 kg/m2.
  • * HbA1C ≤12%.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

TR Therapeutics,

Study Record Dates

2027-02