A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
This is a multi-center, Phase 3, randomized, double-blind, vehicle-controlled study in subjects
with at least one chronic nonhealing VLU. Approximately 440 subjects will be randomized to
one of 2 groups in an equal allocation to receive HP802-247 (Q14 days with Vehicle on the off
weeks) or Vehicle alone on a weekly basis for 12 weeks or until wound closure, whichever
Treatment randomization will be stratified by the subject[Right Quote]s wound size (cm2) and duration
(week) at baseline with each stratification factor having two levels: small wound size vs. large
wound size, and short wound duration vs. long wound duration. The details of the stratification
factors and the process of the stratified randomization will be provided in the statistical analysis
Subjects who achieve wound closure during treatment will be required to return for confirmation
of closure at an additional two (2) consecutive visits two (2) weeks apart, Visit 15 and Visit 17.
All subjects regardless of wound closure will be required to complete the End of Treatment
Assessment or Early Discontinuation Visit 17 and continue into a follow-up period of 8 weeks
(Visit 18 and 19) consisting of monthly visits. Upon completion or early termination, all of the
subjects who received at least one randomized treatment in the current trial will be encouraged to
enroll into an observational safety follow-up study under a separate protocol. The purpose of the
separate protocol will be to continue with a safety assessment every 2 months until a total of
12 months of follow-up has been achieved, based on the date of initial test article
1. Provide informed consent.
2. Age greater than or equal to 18 years and of either sex.
3. Willing to comply with protocol instructions, including allowing all study assessments.
4. Men, women not of child-bearing potential, and women of child-bearing potential
(those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral
oophorectomy], or not post-menopausal), may participate in the study if they meet all of
5. Not breast feeding
6. A negative serum pregnancy test at screening
7. Agree to undertake a serum pregnancy test upon exiting the study
8. Do not intend to become pregnant during the study
9. Using adequate birth control methods and agree to continue using those methods
for the duration of the study
10. Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus),
with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2 confirmed using the ARANZ Silhouette
wound imaging and measurement device.
11. Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular
or venous incompetence.
12. Arterial supply adequacy confirmed by any one of the following:
• Great toe pressure ≥ 50 mm/Hg
• Systolic blood pressure Ankle Brachial Index (ABI) in the range greater than or equal to 0.8 to ≤ 1.1
• TcPO2 greater than or equal to 40 mmHg from the foot
13. Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon,
muscle, or bone.
14. Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
15. Acceptable state of health and nutrition with pre-albumin levels of ≥ 10 mg/dL
(0.10 g/L), serum albumin ≥ 2.0 g/dL (20 g/L), per the Screening central lab report, and
no abnormal laboratory values that, in the opinion of the Principal Investigator, place
the subject at risk for the study. Refer to Appendix 18.2.1for further details.
16. Per Screening central lab, an HbA1C < 12.0%
17. Karnofsky score ≥ 60%