Clinical trial NCT02392390: Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds
Official title: Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcer
Keywords: Topical Dynamic Phototherapy
Microbiota
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
timeFrame: Baseline (Day 0)
measure: The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
timeFrame: Day 0: immediately after Metvixia rinsing and right before phototherapy
measure: The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
timeFrame: Day 0: immediately after phototherapy
Secondary outcomes:
measure: The percentage of commensal bacteria among bacteria species isolated per sample
timeFrame: Baseline (Day 0)
measure: The percentage of commensal bacteria among bacteria species isolated per sample
timeFrame: Day 0: immediately after Metvixia rinsing and right before phototherapy
measure: The percentage of commensal bacteria among bacteria species isolated per sample
timeFrame: Day 0: immediately after phototherapy
measure: The number of bacteria taxa detected per sample
timeFrame: Baseline (Day 0)
measure: The number of bacteria taxa detected per sample
timeFrame: Day 0: immediately after Metvixia rinsing and right before phototherapy
measure: The number of bacteria taxa detected per sample
timeFrame: Day 0: immediately after phototherapy
measure: The diversity of bacteria taxa detected per sample (Shannon's H with log2)
timeFrame: Baseline (Day 0)
measure: The diversity of bacteria taxa detected per sample (Shannon's H with log2)
timeFrame: Day 0: immediately after Metvixia rinsing and right before phototherapy
measure: The diversity of bacteria taxa detected per sample (Shannon's H with log2)
timeFrame: Day 0: immediately after phototherapy
measure: The number of functional groups detected per sample
timeFrame: Baseline (Day 0)
measure: The number of functional groups detected per sample
timeFrame: Day 0: immediately after Metvixia rinsing and right before phototherapy
measure: The number of functional groups detected per sample
timeFrame: Day 0: immediately after phototherapy
measure: The diversity of functional groups detected per sample (Shannon's H with log2)
timeFrame: Baseline (Day 0)
measure: The diversity of functional groups detected per sample (Shannon's H with log2)
timeFrame: Day 0: immediately after Metvixia rinsing and right before phototherapy
measure: The diversity of functional groups detected per sample (Shannon's H with log2)
timeFrame: Day 0: immediately after phototherapy
measure: Adverse events
timeFrame: Day 0
measure: Adverse events
timeFrame: Day 7
measure: Visual analog scale for pain during the phototherapy session
timeFrame: Day 0
Other outcomes:
measure: Age in years
timeFrame: Day 0 (baseline)
measure: Gender
timeFrame: Day 0 (baseline)
measure: Body mass index
timeFrame: Day 0 (baseline)
measure: Number of lesions
timeFrame: Day 0 (baseline)
measure: Initial wound care or follow up?
timeFrame: Day 0 (baseline)
measure: If follow up visit, is the wound aggravated, stable or improving?
timeFrame: Day 0 (baseline)
measure: If follow up visit, is the wound aggravated, stable or improving?
timeFrame: Day 7
measure: Age of the target lesion in days
timeFrame: Day 0 (baseline)
measure: Location of the target lesion
timeFrame: Day 0 (baseline)
measure: Wound appearance
timeFrame: Day 0 (baseline)
measure: Presence/absence of signs of infection
timeFrame: Day 0 to Day 7
measure: Change in the size of the wound (mm^2)
timeFrame: Day 7 versus baseline
measure: Irradiation dose (minutes)
timeFrame: Day 0
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Laurent Meunier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: