Leg Ulcer
Conditions
Keywords
Topical Dynamic Phototherapy, Microbiota
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
Interventions
PROCEDURETopical Dynamic Phototherapy (TDP)
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.
DRUGMetvixia cream
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample | Baseline (Day 0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of bacteria taxa detected per sample | Baseline (Day 0) | — |
| The diversity of bacteria taxa detected per sample (Shannon's H with log2) | Baseline (Day 0) | Shannon's H with log2 |
| The number of functional groups detected per sample | Baseline (Day 0) | Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci. |
| The percentage of commensal bacteria among bacteria species isolated per sample | Baseline (Day 0) | — |
| Adverse events | Day 0 | — |
| Visual analog scale for pain during the phototherapy session | Day 0 | Scale from 0 to 10 |
| The diversity of functional groups detected per sample (Shannon's H with log2) | Baseline (Day 0) | Shannon's H with log 2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wound appearance | Day 0 (baseline) | burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor |
| Presence/absence of signs of infection | Day 0 to Day 7 | Purulent discharge, local inflammatory signs, rough bony contact, associated osteitis without bone contact, bacteremia, severe sepsis |
| Age in years | Day 0 (baseline) | — |
| Irradiation dose (minutes) | Day 0 | — |
| Change in the size of the wound (mm^2) | Day 7 versus baseline | — |
| Gender | Day 0 (baseline) | — |
| Body mass index | Day 0 (baseline) | — |
| Number of lesions | Day 0 (baseline) | — |
| Initial wound care or follow up? | Day 0 (baseline) | — |
| If follow up visit, is the wound aggravated, stable or improving? | Day 0 (baseline) | — |
| Age of the target lesion in days | Day 0 (baseline) | — |
| Location of the target lesion | Day 0 (baseline) | Heel, internal malleolus or external malleolus |
Countries
France
Outcome results
None listed