CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
NCT Number: NCT02392390
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nîmes, 30029, France
The secondary objectives of this study are:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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.
Time frame: Baseline (Day 0)
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
Time frame: Day 0: immediately after phototherapy
Time frame: Baseline (Day 0)
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
Time frame: Day 0: immediately after phototherapy
Time frame: Baseline (Day 0)
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
Time frame: Day 0: immediately after phototherapy
Time frame: Baseline (Day 0)
Shannon's H with log2
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
Shannon's H with log2
Time frame: Day 0: immediately after phototherapy
Shannon's H with log2
Time frame: Baseline (Day 0)
Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.
Time frame: Day 0: immediately after phototherapy
Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.
Time frame: Baseline (Day 0)
Shannon's H with log 2
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
Shannon's H with log 2
Time frame: Day 0: immediately after phototherapy
Shannon's H with log 2
Time frame: Day 0
Time frame: Day 7
Time frame: Day 0
Scale from 0 to 10
Time frame: Day 0 (baseline)
Time frame: Day 0 (baseline)
Time frame: Day 0 (baseline)
Time frame: Day 0 (baseline)
Time frame: Day 0 (baseline)
Time frame: Day 0 (baseline)
Time frame: Day 7
Time frame: Day 0 (baseline)
Time frame: Day 0 (baseline)
Heel, internal malleolus or external malleolus
Time frame: Day 0 (baseline)
burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time frame: Day 0 to Day 7
Purulent discharge, local inflammatory signs, rough bony contact, associated osteitis without bone contact, bacteremia, severe sepsis
Time frame: Day 7 versus baseline
Time frame: Day 0
Centre Hospitalier Universitaire de Nīmes
Other
Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study
Acronym: PDT-Bactério
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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