TRIVIA Study 

You will first need to take part in a screening visit to determine if you qualify. A screening visit is an initial assessment that will determine whether you qualify for a study by having you answer questions about your medical history and undergoing certain tests. The tests will include taking your blood and urine samples, a physical examination, questions about your health and treatments, and a full review of your medical history. If you qualify and agree to participate, you will enroll into the research study.

If you are determined eligible for the study and agree to participate, you will be in the study for up to 30 weeks, with up to 25 visits. The study is divided into 3 study phases:

Screening Period (about 14 days):
During this period, the study team will conduct various diagnostic examinations to confirm your eligibility to participate in the study. Your venous leg ulcer will be examined, photographed, cleaned, debrided, and bandaged. Additional assessments will include a full physical examination, electrocardiogram, medical history, and laboratory tests from blood and urine samples taken.

Treatment Period (about 16 weeks):
If you continue to qualify for the study, you will enter into the study Treatment Period where you will return to site twice weekly during the first 4 weeks and then once weekly for the remaining 8 weeks until your ulcer heals. At every visit, your venous leg ulcer will be examined, photographed, cleaned, debrided, and bandaged. You will either be randomized to receive the study drug and standard of care or receive standard of care alone. If you are randomized to receive the study drug, the site staff will additionally apply the drug to your ulcer at every visit.  You will undergo safety assessments including physical examinations, electrocardiograms, and laboratory tests from blood and urine samples taken.
If your venous leg ulcer does not heal you will complete your participation at the end of week 16. You may be contacted to follow up if needed.
You can choose to leave the study at any time for any reason, without any penalty to yourself.

Follow-up Period (about 3 months):
If your venous leg ulcer heals during the treatment period, you will be provided compression wraps and enter the Follow-up Period. During the Follow-up Period, you will be contacted by the site by telephone to check up on compliance with compression and to ensure you are taking proper care of your ulcer.  You will return back to the site at the end of the 3 months for your final visit where they will check the status of your ulcer.

The investigational drug, also called the study drug, being studied is a topical hydrogel. The active ingredient is Glucoprime. The study will determine whether using the drug with compression bandaging can heal your ulcer faster than compression bandaging alone.

If you qualify to participate, wound compression bandaging, study drug (if applicable), and all study related procedures will be provided to you at no charge.

There are risks and benefits of taking part in any clinical research study. These risks and benefits are outlined in detail in the Informed Consent Form that you must read and sign before you can take part in the study. For example, you may benefit from receiving standard of care for your Venous Leg Ulcer.  Standard of care is what most physicians agree is the best treatment option available for the condition being studied.  You may benefit from receiving study drug, although this cannot be guaranteed. Your health may get better, it may stay the same, or it may get worse. You should discuss the risks and benefits of participation with your health care providers.
Study-related health assessments, along with wound bandaging and any study-related drug, equipment, and supplies are provided at no charge to you. Often, reasonable study-related expenses (such as time and travel) will be reimbursed.

In order to qualify for the TRIVIA study, you must meet certain criteria, including:

• Male or Females aged 18 and older
• Having a Venous Leg Ulcer (VLU) that has not healed for at least 4 weeks
• Leg Ulcer is between the sizes of 2 cm² and 12 cm²
• Willing to adhere to wound bandaging and compression requirements as well as other study procedures and visits

The trial is being conducted by TR Therapeutics, Inc., a wholly owned subsidiary of Tissue Repair Pty, Ltd. TR Therapeutics is in Washington D.C. in the United States and our parent company Tissue Repair is located in Sydney, Australia