A Prospective, Randomized, Double-Blind Controlled Study of WPP-201 for the Safety and Efficacy of Treatment of Venous Leg Ulcers

A Prospective, Randomized Double-Blind Controlled Study of WPP-201 for the Safety and Efficacy of Treatment of Venous Leg Ulcers

To test safety and efficacy of Bacteriophage on Venous Leg Ulcers.

This is a prospective, randomized, controlled double blind study in patients with full thickness venous leg ulcers of greater than 30 days duration evaluating the safety of WPP-201 on the healing of those wounds.

Inclusion Criteria:

1. Subject must have evidence of hemosiderosis, stasis dermatitis, or dermato liposclerosis; AND edema in the lower extremity on which the wound is present.
2. Subject must be at least 18 years of age.
3. Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator.
4. The post-debridement ulcer at Day 0 must be free of all necrotic tissue and undermining.
5. The study ulcer must be from 1 cm2 to 60 cm2 in size.
6. The study ulcer must have been present for greater than 30 days at study Day -7.
7. The study ulcer is separated at least 4 cm from all other ulcers at Study Day -7 and Study Day 0 and has a margin of intact skin sufficient for anchoring of the required study dressings.
8. The subjects' Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day 0.
9. The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form.
10. The subject must be available for evaluation on a weekly basis for the twelve (12) weeks of the study. Visits at Week 13 and Week 14 are required for initial wound healing, which is achieved in study Week 11 or 12. The Investigator will evaluate both groups at Week 16 and Month 6. Subjects must be available for evaluation at Week 16 and Month 6.
11. Subjects' TCpO2 must be equal to or greater than 20 mm of mercury and ABI greater than 0.7.

Exclusion Criteria:

1. Subject whose ulcer has healed 30% or greater from the evaluation Study day -7 to the post-debridement Study Day 0 as determined by wound tracings using VisitrakTM.

2. A history of alcohol or substance abuse, within the previous year, which could, or in the judgment of the Investigator, would interfere with study compliance or protocol requirements.

3. Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.

4. Subject with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. Anticipated use of the above during the study period will also exclude a subject from entry into the study. Topical and inhaled corticosteroids are not prohibited.

5. Subject will be excluded if:

   • Serum sodium is less than 130 or greater than 147
   • Potassium is greater than 5.4 or less than 3.3
   • Glucose is less than 55
   • Blood urea nitrogen is greater than 31
   • Creatinine is greater than 2.1
   • Calcium is less than 7
   • CPK is greater than 3 times upper limits of normal
   • Albumin is less than 2.5
   • Total protein is less than 5
   • Alkaline phosphatase is greater than 3 times upper limits of normal
   • ALT/AST is greater than 5 times upper limits of normal
   • Hemoglobin is less than 8
   • White blood count is greater than 20,000 or below 1,000

6. Subject who is pregnant, lactating or has a positive serum hCG as determined by laboratory testing is excluded from the study.

7. Subject who demonstrates allergies to any component in WPP-201 (phage or saline).

8. Subject who has previously received any application of bacteriophage.