Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

NCT ID: NCT02392390

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-03-31

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

Conditions

Leg Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Topical Dynamic Phototherapy (TDP)

Intervention Type: 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.

Metvixia cream

Intervention Type: DRUG

Interventions

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.

Intervention Type: PROCEDURE

Metvixia cream

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Meunier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2014-004668-40

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2014/LM-01

Identifier Type: -

Identifier Source: org_study_id