Photodynamic topical antimicrobial therapy for infected foot ulcers in patients with diabetes: a randomized, double-blind, placebo-controlled study--the D.A.N.T.E (Diabetic ulcer Antimicrobial New Topical treatment Evaluation) study.

Abstract

This study was designed to assess the antimicrobial effect and tolerability of a single dose of a photo-activated gel containing RLP068 in the treatment for infected foot ulcers in subjects with diabetes. A randomized, double-blind, parallel series, placebo-controlled phase IIa trial was performed with three concentrations of RLP068 (0.10, 0.30, and 0.50 %), measuring total and pathogen microbial load on Day 1 (before and 1 h after topical gel application and photoactivation with 689 nm red light), on Days 3, 8, and 15, as add-on to systemic treatment with amoxicillin and clavulanic acid. Blood samples were also drawn 1, 2, and 48 h after administration for the assessment of systemic drug absorption. The trial was performed on 62 patients aged ≥18 years, with type 1 or type 2 diabetes and infected foot ulcer, with an area of 2-15 cm(2) and a maximum diameter ≤4.6 cm. A dose-dependent reduction in total microbial load was observed (-1.92 ± 1.21, -2.94 ± 1.60, and -3.00 ± 1.82 LogCFU/ml for 0.10, 0.30, and 0.50 % RPL068 vs. -1.00 ± 1.02 LogCFU/ml with placebo) immediately after illumination, with a progressive fading of the effect during follow-up. No safety issues emerged from the analysis of adverse events. Systemic absorption of RLP068 was negligible. Photodynamic antimicrobial treatment with RLP068 of infected diabetic foot ulcers is well tolerated and produces a significant reduction in germ load. Further clinical trials are needed to verify the efficacy of this approach as add-on to systemic antibiotic treatment.

• Authors: Edoardo Mannucci, Stefano Genovese, Matteo Monami, Giovanni Navalesi, Francesco Dotta, Roberto Anichini, Fabio Romagnoli, Gianfranco Gensini
• Journal: Acta diabetologica (Acta Diabetol) Vol. 51 Issue 3 Pg. 435-40 ( 2014) ISSN: 1432-5233 [Electronic] Germany
• PMID: 24352342 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Indoles
• Organometallic Compounds
• Photosensitizing Agents
• RLP068

Topics

• Adult
• Anti-Bacterial Agents (chemistry, therapeutic use)
• Bacteria (drug effects)
• Diabetes Mellitus, Type 1 (complications)
• Diabetes Mellitus, Type 2 (complications)
• Diabetic Foot (drug therapy, etiology, microbiology)
• Drug Evaluation
• Female
• Humans
• Indoles (therapeutic use)
• Male
• Middle Aged
• Organometallic Compounds (therapeutic use)
• Photochemotherapy
• Photosensitizing Agents (chemistry, therapeutic use)
• Ulcer (drug therapy, etiology, microbiology)
• Young Adult