Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study

Conditions
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Leg Ulcer

Intervention / Treatment
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* Procedure: Topical Dynamic Phototherapy (TDP)
* Drug: Metvixia cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study population<br>A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment. Intervention: Topical Dynamic Phototherapy (TDP) | Procedure: Topical Dynamic Phototherapy (TDP)<br>* Metvixia cream is applied to the lesion (about 1mm thickness) and the treated zone is covered with an opaque dression for 3 hours. Any residual cream is removed an and the lesion immediately rinsed with saline solution when uncovering. One session (8 minutes) of phototherapy is then performed using an Altilite lamp in accordance with HAS (haute authorité de santé) recommendations.<br>Drug: Metvixia cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample |  | Baseline (Day 0) | 
| The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample |  | Day 0: immediately after Metvixia rinsing and right before phototherapy | 
| The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample |  | Day 0: immediately after phototherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of commensal bacteria among bacteria species isolated per sample |  | Baseline (Day 0) | 
| The percentage of commensal bacteria among bacteria species isolated per sample |  | Day 0: immediately after Metvixia rinsing and right before phototherapy | 
| The percentage of commensal bacteria among bacteria species isolated per sample |  | Day 0: immediately after phototherapy | 
| The number of bacteria taxa detected per sample |  | Baseline (Day 0) | 
| The number of bacteria taxa detected per sample |  | Day 0: immediately after Metvixia rinsing and right before phototherapy | 
| The number of bacteria taxa detected per sample |  | Day 0: immediately after phototherapy | 
| The diversity of bacteria taxa detected per sample (Shannon's H with log2) | Shannon's H with log2 | Baseline (Day 0) | 
| The diversity of bacteria taxa detected per sample (Shannon's H with log2) | Shannon's H with log2 | Day 0: immediately after Metvixia rinsing and right before phototherapy | 
| The diversity of bacteria taxa detected per sample (Shannon's H with log2) | Shannon's H with log2 | Day 0: immediately after phototherapy | 
| The number of functional groups detected per sample | Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci. | Baseline (Day 0) | 
| The number of functional groups detected per sample | Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci. | Day 0: immediately after Metvixia rinsing and right before phototherapy | 
| The number of functional groups detected per sample | Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci. | Day 0: immediately after phototherapy | 
| The diversity of functional groups detected per sample (Shannon's H with log2) | Shannon's H with log 2 | Baseline (Day 0) | 
| The diversity of functional groups detected per sample (Shannon's H with log2) | Shannon's H with log 2 | Day 0: immediately after Metvixia rinsing and right before phototherapy | 
| The diversity of functional groups detected per sample (Shannon's H with log2) | Shannon's H with log 2 | Day 0: immediately after phototherapy | 
| Adverse events |  | Day 0 | 
| Adverse events |  | Day 7 | 
| Visual analog scale for pain during the phototherapy session | Scale from 0 to 10 | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical Dynamic Phototherapy, Microbiota