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

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcers
• Intervention / Treatment: Drug: Bacteriophage; Drug: WPP-201 Bacteriophage; Drug: Bacteriophages

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • Southweast Regional Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bacteriophages

Drug: Bacteriophage; WPP-201 is a pH neutral, polyvalent phage preparation, which contains 8 bacteriophages ("component bacteriophages" or "component phages") lytic for P. aeruginosa, S. aureus, and E. coli (Table 1). The cocktail contains a concentration of approximately 1 x 109 PFU/ml of each of the component monophages. The phage component of WPP-201 is roughly estimated to be £ 0.5 ppm by weight and the remainder is phosphate-buffered saline containing < 1,000 ppm total organic carbon from the growth medium and biomass. All phages contained in the preparation have been originally isolated from the environment, and they have not been genetically manipulated in any way (i.e., the preparation is 100% natural). WPP-201 contains no preservatives and antioxidants.; Other Names: WPP-201- Bacteriophage; Drug: WPP-201 Bacteriophage; WPP-201 is a pH neutral, polyvalent phage preparation, which contains 8 bacteriophages ("component bacteriophages" or "component phages") lytic for P. aeruginosa, S. aureus, and E. coli (Table 1). The cocktail contains a concentration of approximately 1 x 109 PFU/ml of each of the component monophages. The phage component of WPP-201 is roughly estimated to be £ 0.5 ppm by weight and the remainder is phosphate-buffered saline containing < 1,000 ppm total organic carbon from the growth medium and biomass. All phages contained in the preparation have been originally isolated from the environment, and they have not been genetically manipulated in any way (i.e., the preparation is 100% natural). WPP-201 contains no preservatives and antioxidants.; Other Names: WPP-201; Drug: Bacteriophages; WPP-201 is a pH neutral, polyvalent phage preparation, which contains 8 bacteriophages ("component bacteriophages" or "component phages") lytic for P. aeruginosa, S. aureus, and E. coli (Table 1). The cocktail contains a concentration of approximately 1 x 109 PFU/ml of each of the component monophages. The phage component of WPP-201 is roughly estimated to be £ 0.5 ppm by weight and the remainder is phosphate-buffered saline containing < 1,000 ppm total organic carbon from the growth medium and biomass. All phages contained in the preparation have been originally isolated from the environment, and they have not been genetically manipulated in any way (i.e., the preparation is 100% natural). WPP-201 contains no preservatives and antioxidants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this Phase 1 study is to evaluate the safety of the use of WPP-201.	2 years

Collaborators and Investigators

• Sponsor: Southwest Regional Wound Care Center

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 6, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: WPP-201
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 56-RW-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No