Overview

Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire de NÄ«mes
Treatments:
Methyl 5-aminolevulinate
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