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

Primary Purpose

Leg Ulcer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Topical Dynamic Phototherapy (TDP)
Metvixia cream
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer focused on measuring Topical Dynamic Phototherapy, Microbiota

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The study population

Arm Description

A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment. Intervention: Topical Dynamic Phototherapy (TDP)

Outcomes

Primary Outcome Measures

The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample

Secondary Outcome Measures

The percentage of commensal bacteria among bacteria species isolated per sample
The percentage of commensal bacteria among bacteria species isolated per sample
The percentage of commensal bacteria among bacteria species isolated per sample
The number of bacteria taxa detected per sample
The number of bacteria taxa detected per sample
The number of bacteria taxa detected per sample
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Shannon's H with log2
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Shannon's H with log2
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Shannon's H with log2
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.
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.
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.
The diversity of functional groups detected per sample (Shannon's H with log2)
Shannon's H with log 2
The diversity of functional groups detected per sample (Shannon's H with log2)
Shannon's H with log 2
The diversity of functional groups detected per sample (Shannon's H with log2)
Shannon's H with log 2
Adverse events
Adverse events
Visual analog scale for pain during the phototherapy session
Scale from 0 to 10

Full Information

First Posted
March 13, 2015
Last Updated
April 6, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02392390
Brief Title
Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds
Acronym
PDT-Bactério
Official Title
Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer
Keywords
Topical Dynamic Phototherapy, Microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The study population
Arm Type
Experimental
Arm Description
A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment. Intervention: Topical Dynamic Phototherapy (TDP)
Intervention Type
Procedure
Intervention Name(s)
Topical Dynamic Phototherapy (TDP)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Metvixia cream
Primary Outcome Measure Information:
Title
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Time Frame
Baseline (Day 0)
Title
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Time Frame
Day 0: immediately after Metvixia rinsing and right before phototherapy
Title
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Time Frame
Day 0: immediately after phototherapy
Secondary Outcome Measure Information:
Title
The percentage of commensal bacteria among bacteria species isolated per sample
Time Frame
Baseline (Day 0)
Title
The percentage of commensal bacteria among bacteria species isolated per sample
Time Frame
Day 0: immediately after Metvixia rinsing and right before phototherapy
Title
The percentage of commensal bacteria among bacteria species isolated per sample
Time Frame
Day 0: immediately after phototherapy
Title
The number of bacteria taxa detected per sample
Time Frame
Baseline (Day 0)
Title
The number of bacteria taxa detected per sample
Time Frame
Day 0: immediately after Metvixia rinsing and right before phototherapy
Title
The number of bacteria taxa detected per sample
Time Frame
Day 0: immediately after phototherapy
Title
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Description
Shannon's H with log2
Time Frame
Baseline (Day 0)
Title
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Description
Shannon's H with log2
Time Frame
Day 0: immediately after Metvixia rinsing and right before phototherapy
Title
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Description
Shannon's H with log2
Time Frame
Day 0: immediately after phototherapy
Title
The number of functional groups detected per sample
Description
Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.
Time Frame
Baseline (Day 0)
Title
The number of functional groups detected per sample
Description
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
Title
The number of functional groups detected per sample
Description
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
Title
The diversity of functional groups detected per sample (Shannon's H with log2)
Description
Shannon's H with log 2
Time Frame
Baseline (Day 0)
Title
The diversity of functional groups detected per sample (Shannon's H with log2)
Description
Shannon's H with log 2
Time Frame
Day 0: immediately after Metvixia rinsing and right before phototherapy
Title
The diversity of functional groups detected per sample (Shannon's H with log2)
Description
Shannon's H with log 2
Time Frame
Day 0: immediately after phototherapy
Title
Adverse events
Time Frame
Day 0
Title
Adverse events
Time Frame
Day 7
Title
Visual analog scale for pain during the phototherapy session
Description
Scale from 0 to 10
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Age in years
Time Frame
Day 0 (baseline)
Title
Gender
Time Frame
Day 0 (baseline)
Title
Body mass index
Time Frame
Day 0 (baseline)
Title
Number of lesions
Time Frame
Day 0 (baseline)
Title
Initial wound care or follow up?
Time Frame
Day 0 (baseline)
Title
If follow up visit, is the wound aggravated, stable or improving?
Time Frame
Day 0 (baseline)
Title
If follow up visit, is the wound aggravated, stable or improving?
Time Frame
Day 7
Title
Age of the target lesion in days
Time Frame
Day 0 (baseline)
Title
Location of the target lesion
Description
Heel, internal malleolus or external malleolus
Time Frame
Day 0 (baseline)
Title
Wound appearance
Description
burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time Frame
Day 0 (baseline)
Title
Presence/absence of signs of infection
Description
Purulent discharge, local inflammatory signs, rough bony contact, associated osteitis without bone contact, bacteremia, severe sepsis
Time Frame
Day 0 to Day 7
Title
Change in the size of the wound (mm^2)
Time Frame
Day 7 versus baseline
Title
Irradiation dose (minutes)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Meunier, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

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