Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

Leg Ulcer Clinical Trial

— PDT-Bactério  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392390
• Other study ID #: LOCAL/2014/LM-01
• Secondary ID: 2014-004668-40
• Status: Completed
• Phase: N/A
• First received: March 13, 2015
• Last updated: April 6, 2016
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age in years		Day 0 (baseline)	No
Other	Gender		Day 0 (baseline)	No
Other	Body mass index		Day 0 (baseline)	No
Other	Number of lesions		Day 0 (baseline)	No
Other	Initial wound care or follow up?		Day 0 (baseline)	No
Other	If follow up visit, is the wound aggravated, stable or improving?		Day 0 (baseline)	No
Other	If follow up visit, is the wound aggravated, stable or improving?		Day 7	No
Other	Age of the target lesion in days		Day 0 (baseline)	No
Other	Location of the target lesion	Heel, internal malleolus or external malleolus	Day 0 (baseline)	No
Other	Wound appearance	burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Day 0 (baseline)	No
Other	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	No
Other	Change in the size of the wound (mm^2)		Day 7 versus baseline	No
Other	Irradiation dose (minutes)		Day 0	No
Primary	The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample		Baseline (Day 0)	No
Primary	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	No
Primary	The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample		Day 0: immediately after phototherapy	No
Secondary	The percentage of commensal bacteria among bacteria species isolated per sample		Baseline (Day 0)	No
Secondary	The percentage of commensal bacteria among bacteria species isolated per sample		Day 0: immediately after Metvixia rinsing and right before phototherapy	No
Secondary	The percentage of commensal bacteria among bacteria species isolated per sample		Day 0: immediately after phototherapy	No
Secondary	The number of bacteria taxa detected per sample		Baseline (Day 0)	No
Secondary	The number of bacteria taxa detected per sample		Day 0: immediately after Metvixia rinsing and right before phototherapy	No
Secondary	The number of bacteria taxa detected per sample		Day 0: immediately after phototherapy	No
Secondary	The diversity of bacteria taxa detected per sample (Shannon's H with log2)	Shannon's H with log2	Baseline (Day 0)	No
Secondary	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	No
Secondary	The diversity of bacteria taxa detected per sample (Shannon's H with log2)	Shannon's H with log2	Day 0: immediately after phototherapy	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	The diversity of functional groups detected per sample (Shannon's H with log2)	Shannon's H with log 2	Baseline (Day 0)	No
Secondary	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	No
Secondary	The diversity of functional groups detected per sample (Shannon's H with log2)	Shannon's H with log 2	Day 0: immediately after phototherapy	No
Secondary	Adverse events		Day 0	Yes
Secondary	Adverse events		Day 7	Yes
Secondary	Visual analog scale for pain during the phototherapy session	Scale from 0 to 10	Day 0	Yes