Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416462
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-10-02
Brief Title:
Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot Double Blind Randomized Controlled Clinical Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic foot ulcer affects 105 of the Brazilianworld population compromising the quality of life of these patients and burdening the public health system Studies show that antimicrobial photodynamic therapy aPDT accelerates its repair however there is not enough evidence for decision-making in clinical practice which prevents this treatment from being used on a large scale Controlled and randomized clinical studies are needed to increase the level of evidence on this subject promoting the improvement of the quality of life of people affected by diabetic foot ulcers The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds
Detailed Description:
Diabetic foot ulcer affects 105 of the Brazilianworld population compromising the quality of life of these patients and burdening the public health system Studies show that antimicrobial photodynamic therapy aPDT accelerates its repair however there is not enough evidence for decision-making in clinical practice which prevents this treatment from being used on a large scale Controlled and randomized clinical studies are needed to increase the level of evidence on this subject promoting the improvement of the quality of life of people affected by diabetic foot ulcers The aim of this study is to analyze the action of antimicrobial photodynamic therapy on the quality of the wound and tissue repair process using the Bates-Jensen scale in people affected by diabetic foot wounds A clinical controlled randomized and double-blind study will be carried out Patients will be randomized 11 into 2 groups 1 experimental n 45 - standard care from the Polyclinic wound sector aPDT and 2 control n 45 - standard care simulation of use aPDT with equipment off All patients will be seen three times a week with 10 sessions of aPDT or simulation performed by the same operator A cluster with an average radiant power of 100 mW radiant energy per emitter of 6 Jcm² of red light wavelength 660 nm will be used The research will be carried out in a Municipal Health Center in the city of Rio de Janeiro Patients affected by neuropathic wounds of the diabetic foot assisted by the Programmatic Care Health Coordination will be included 51 The initial assessment will consist of collecting data from medical records to establish the sociodemographic and clinical profile of patients affected by diabetic foot injuries by a researcher blinded to the interventions This scale assesses the size of the lesion depth borders detachment type of necrotic tissue amount of necrotic tissue type of exudate amount of exudate skin color around the wound perilesional tissue edema perilesional tissue hardening granulation tissue epithelialization As secondary outcomes the sensitivity of the foot will be evaluated through neurological evaluation with tuning fork and monofilament the instrument for assessing quality of life - Diabetes-21 the Wagner Scale the evaluation of the degree of ischemia by the Fontaine scale and Runtherford the WiFi and Taxonomy Nursing Outcomes Classification scale that assesses skin integrity Data from this research will be collected after approval by the ethics committee of Universidade Nove de Julho and the City Hall of Rio de Janeiro
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None