Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the
effectiveness of TR 987 gel. It is a two-arm, design: One group will receive twice-weekly
applications of 0.1% TR 987 in a gel base plus SoC for the first 4 weeks. The other group
will receive twice-weekly applications of placebo gel base plus SoC for the same period of
time. After 4 weeks, both groups will receive once weekly applications of their assigned
treatment for the remaining 8 weeks of the trial. The Standard of Care therapy in this study
is multi-layer compression therapy.

Inclusion Criteria:

1. Subject is at least 18 years old

2. Female subjects are not pregnant or breastfeeding.

3. Study ulcer has been present for at least one month and has undergone more than 2
weeks, but less than 12 months of continuous high-strength compression with less than
40% healing.

4. Study ulcer is a minimum of 2.0 cm2 and a maximum of 20.0 cm2, extending through the
full thickness of the skin, but not down to muscle, tendon, or bone at the
randomization visit.

5. Study ulcer has a clean, granulating base with minimal adherent slough at the
randomization visit.

6. If more than one ulcer is present on the same leg, they must be more than 2 cm apart
and only the larger ulcer will be included in the study.

7. Adequate arterial flow, as measured by an Ankle Brachial Pressure Index (ABI) of
greater than 0.75. (Calculations will be made using measurements from both posterior
tibial and dorsalis pedis arteries, as well as both arms) and/or Skin Perfusion
Pressure (SPP) >30.

8. Subject understands and is willing to participate in the clinical study and can comply
with weekly visits and the follow-up regimen.

9. Patient understands and is willing to participate in the clinical study and can comply
with weekly visits and the follow-up regimen.

10. Patient has read and signed the IRB/IEC approved Informed Consent Form before
screening procedures are undertaken.

Exclusion Criteria:

1. Study ulcer deemed by the Investigator to be caused by a medical condition other than
venous insufficiency.

2. Study ulcer exhibits clinical signs and symptoms of infection.

3. Study ulcer requires enzymatic debridement during the study.

4. Study ulcer has undergone 12 or more months of continuous high-strength compression
therapy over its duration.

5. Study ulcer is less than 2.0 cm2 or greater than 20.0 cm2.

6. Study ulcer extends more than 50% below the malleolus.

7. Study ulcer is treated with a topical antibiotic during the screening phase.

8. Study ulcer has been treated with tissue engineered material (e.g., Apligraf® or
Dermagraft®) or other scaffold materials (e.g., Oasis or Matristem) within 30 days
prior to the TV1 Randomization visit.

9. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the
course of the trial.

10. History of radiation at the study ulcer site.

11. Study ulcer decreases in area by 30% or more during the 14 days screening period.

12. Subjects who are unable to understand the aims and objectives of the trial or has a
known history of poor adherence with medical treatment.

13. Presence of any condition(s) that seriously compromises the subject's ability to
complete this study.

14. All females of childbearing potential who are not using a highly effective method of
birth control (failure rate less than 1% per year), such implants, injectables,
combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.