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J Wound Care. 2009 Jun;18(6):237-8, 240-3.

Bacteriophage therapy of venous leg ulcers in humans: results of a phase I safety trial.

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  • 1Department of Psychiatry, University of Minnesota, Minneapolis, USA.

Abstract

OBJECTIVE:

This phase 1 trial set out to examine the safety of a bacteriophage-based preparation for difficult-to-treat wounds.

METHOD:

The intention-to-treat sample comprised 42 patients with chronic venous leg ulcers (VLUs); 39 patients completed the trial. The ulcers were treated for 12 weeks with either a saline control or bacteriophages targeted against Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli. Follow-up continued until week 24.

RESULTS:

No adverse events were attributed to the study product. No significant difference (p>0.05) was determined between the test and control groups for frequency of adverse events, rate of healing, or frequency of healing.

CONCLUSION:

This study found no safety concerns with the bacteriophage treatment. Efficacy of the preparation will need to be evaluated in a phase II efficacy study.

DECLARATION OF INTEREST:

One of the authors (AS) holds an equity interest in Intralytix. The other authors do not have any interest in commercial activities.

[PubMed - indexed for MEDLINE]
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