Bacteriophage therapy of venous leg ulcers in humans: results of a phase I safety trial.
OBJECTIVE
This phase 1 trial set out to examine the safety of a bacteriophage-based preparation for difficult-to-treat wounds.


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
One of the authors (AS) holds an equity interest in Intralytix. The other authors do not have any interest in commercial activities.
Rhoads
D D
DD
Department of Psychiatry, University of Minnesota, Minneapolis, USA.
Wolcott
R D
RD
Kuskowski
M A
MA
Wolcott
B M
BM
Ward
L S
LS
Sulakvelidze
A
A
D001435:Bacteriophages / Q000737:chemistry; D001691:Biological Therapy; D016009:Chi-Square Distribution; D002908:Chronic Disease; D004311:Double-Blind Method; D004927:Escherichia coli Infections / Q000628:therapy; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011552:Pseudomonas Infections / Q000628:therapy; D012449:Safety; D017592:Skin Care / Q000379:methods; D013203:Staphylococcal Infections / Q000628:therapy; D013211:Staphylococcus aureus; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000150:complications / Q000628:therapy*; D014945:Wound Healing; D014946:Wound Infection / Q000209:etiology / Q000628:therapy*