NCT00663091

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Southwest Regional Wound Care Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Venous Leg Ulcers

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-04-22
• Last updated: 2011-09-07

Locations

1 site across 1 country: United States