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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004668-40 | Other Identifier | RCB number |
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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.
The secondary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | Experimental | A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment. Intervention: Topical Dynamic Phototherapy (TDP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Dynamic Phototherapy (TDP) | Procedure | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age in years | Day 0 (baseline) | |
| Gender | Day 0 (baseline) | |
| Body mass index |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Meunier, MD, PhD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Metvixia cream | Drug |
|
| 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 |
| 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) |
| If follow up visit, is the wound aggravated, stable or improving? | Day 7 |
| Age of the target lesion in days | Day 0 (baseline) |
| Location of the target lesion | Heel, internal malleolus or external malleolus | Day 0 (baseline) |
| Wound appearance | burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor | Day 0 (baseline) |
| Presence/absence of signs of infection | Purulent discharge, local inflammatory signs, rough bony contact, associated osteitis without bone contact, bacteremia, severe sepsis | Day 0 to Day 7 |
| Change in the size of the wound (mm^2) | Day 7 versus baseline |
| Irradiation dose (minutes) | Day 0 |