ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	18 April 2016
Main ID:	NCT02392390
Date of registration:	13/03/2015
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
Public title:	Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds PDT-Bactério
Scientific title:	Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study
Date of first enrolment:	October 2015
Target sample size:	10
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02392390
Study type:	Interventional
Study design:	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Laurent Meunier, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Leg Ulcer

Intervention(s)

Drug: Metvixia cream

Procedure: Topical Dynamic Phototherapy (TDP)

Primary Outcome(s)

The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample [Time Frame: Day 0: immediately after phototherapy]

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]

The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample [Time Frame: Baseline (Day 0)]

Secondary Outcome(s)

The percentage of commensal bacteria among bacteria species isolated per sample [Time Frame: Day 0: immediately after Metvixia rinsing and right before phototherapy]

The diversity of bacteria taxa detected per sample (Shannon's H with log2) [Time Frame: Day 0: immediately after Metvixia rinsing and right before phototherapy]

The diversity of functional groups detected per sample (Shannon's H with log2) [Time Frame: Day 0: immediately after Metvixia rinsing and right before phototherapy]

The diversity of functional groups detected per sample (Shannon's H with log2) [Time Frame: Baseline (Day 0)]

The number of functional groups detected per sample [Time Frame: Baseline (Day 0)]

Adverse events [Time Frame: Day 7]

The number of bacteria taxa detected per sample [Time Frame: Day 0: immediately after Metvixia rinsing and right before phototherapy]

Adverse events [Time Frame: Day 0]

The percentage of commensal bacteria among bacteria species isolated per sample [Time Frame: Baseline (Day 0)]

The number of functional groups detected per sample [Time Frame: Day 0: immediately after Metvixia rinsing and right before phototherapy]

The diversity of bacteria taxa detected per sample (Shannon's H with log2) [Time Frame: Baseline (Day 0)]

The number of bacteria taxa detected per sample [Time Frame: Day 0: immediately after phototherapy]

The number of functional groups detected per sample [Time Frame: Day 0: immediately after phototherapy]

The percentage of commensal bacteria among bacteria species isolated per sample [Time Frame: Day 0: immediately after phototherapy]

The number of bacteria taxa detected per sample [Time Frame: Baseline (Day 0)]

Visual analog scale for pain during the phototherapy session [Time Frame: Day 0]

The diversity of bacteria taxa detected per sample (Shannon's H with log2) [Time Frame: Day 0: immediately after phototherapy]

The diversity of functional groups detected per sample (Shannon's H with log2) [Time Frame: Day 0: immediately after phototherapy]

Secondary ID(s)

LOCAL/2014/LM-01

2014-004668-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.