Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Mar 18, 2015

Keywords

ClinConnect Summary

The secondary objectives of this study are:

* To estimate changes in several microbiological parameters over three time periods (before treatment, after applying the Metvixia® and after irradiation during a single TDP session).
* Describe the evolution of the size and appearance of the wound 7d after the start of treatment
* Describe the potential adverse events associated with a TDP session

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient correctly informed concerning study implementation, objectives, constraints and patient rights
• • The patient must have given his/her informed and signed consent
• • The patient must be insured or beneficiary of a health insurance plan
• • The patient presents with one or more leg ulcers (artieral, venous or mixed)
• • Afebrile patient without periulcerous erythema and who does not require antibiotic therapy
• • Patient who has not received antibiotic treatment during the last 7 Days
• • Nota bene: Patients with multiple ulcers at different stages will be included for the wound corresponding to the highest stage. If the patient has multiple ulcers atn the same stage, the deepest wound will be considered.
• Exclusion Criteria:
• • The patient is participating in another interventional study, has participated in another interventional study with the past 3 months, or is in an exclusion period determined by a previous study
• • The patient is under judicial protection, under tutorship or curatorship
• • The patient refuses to sign the consent
• • It is impossible to correctly inform the patient
• • The patient is pregnant, parturient, or breastfeeding
• • The patient has a contraindication for a treatment used in this study
• • Patient with an infected leg ulcer treated with antibiotics
• • Patients on curative anticoagulation