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

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

Conditions
Venous Leg Ulcers
Interventions
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."

Trial Locations (1)

79410

Southweast Regional Wound Care Center, Lubbock

All Listed Sponsors
lead

Southwest Regional Wound Care Center

OTHER

NCT00663091 - A Prospective, Randomized, Double-Blind Controlled Study of WPP-201 for the Safety and Efficacy of Treatment of Venous Leg Ulcers | Biotech Hunter | Biotech Hunter