Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds
- Conditions
- Leg Ulcer
- Interventions
- Procedure: Topical Dynamic Phototherapy (TDP)
- Registration Number
- NCT02392390
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description The study population Topical Dynamic Phototherapy (TDP) A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment. Intervention: Topical Dynamic Phototherapy (TDP) The study population Metvixia cream A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment. Intervention: Topical Dynamic Phototherapy (TDP)
- Primary Outcome Measures
Name Time Method The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample Day 0: immediately after phototherapy
- Secondary Outcome Measures
Name Time Method The diversity of functional groups detected per sample (Shannon's H with log2) Day 0: immediately after phototherapy Shannon's H with log 2
Visual analog scale for pain during the phototherapy session Day 0 Scale from 0 to 10
The diversity of bacteria taxa detected per sample (Shannon's H with log2) Day 0: immediately after phototherapy Shannon's H with log2
The number of functional groups detected per sample Day 0: immediately after phototherapy Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.
Adverse events Day 7 The percentage of commensal bacteria among bacteria species isolated per sample Day 0: immediately after phototherapy The number of bacteria taxa detected per sample Day 0: immediately after phototherapy
Trial Locations
- Locations (1)
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France