Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds (PDT-Bactério)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Leg Ulcer

Treatments: Drug: Metvixia cream; Procedure: Topical Dynamic Phototherapy (TDP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02392390

LOCAL/2014/LM-01

2014-004668-40 (Other Identifier)

Details and patient eligibility

About

The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP.

Full description

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

The study population

Experimental group

Description:

A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment. Intervention: Topical Dynamic Phototherapy (TDP)

Treatment:

Drug: Metvixia cream

Procedure: Topical Dynamic Phototherapy (TDP)