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

J Wound Care. 2009 Jun;18(6):237-8, 240-3. doi: 10.12968/jowc.2009.18.6.42801.


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.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Bacteriophages* / chemistry
  • Biological Therapy
  • Chi-Square Distribution
  • Chronic Disease
  • Double-Blind Method
  • Escherichia coli Infections / therapy
  • Female
  • Humans
  • Linear Models
  • Male
  • Middle Aged
  • Prospective Studies
  • Pseudomonas Infections / therapy
  • Safety
  • Skin Care / methods
  • Staphylococcal Infections / therapy
  • Staphylococcus aureus
  • Treatment Outcome
  • Varicose Ulcer / complications
  • Varicose Ulcer / therapy*
  • Wound Healing
  • Wound Infection / etiology
  • Wound Infection / therapy*