Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds (PDT-Bactério)

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

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcer
• Intervention / Treatment: Procedure: Topical Dynamic Phototherapy (TDP); Drug: Metvixia cream

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The study population; 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); 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.; Drug: Metvixia cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
Adverse events		Day 7
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
Visual analog scale for pain during the phototherapy session	Scale from 0 to 10	Day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age in years		Day 0 (baseline)
Body mass index		Day 0 (baseline)
Gender		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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Laurent Meunier, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Microbiota; Topical Dynamic Phototherapy
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Leg Ulcer; Photosensitizing Agents; Dermatologic Agents; Methyl 5-aminolevulinate
• Other Study ID Numbers: LOCAL/2014/LM-01; 2014-004668-40 (Other Identifier: RCB number)