Clinical trial NCT06416462: Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot
Official title: Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot: Double Blind Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic foot ulcer affects 10.5% of the Brazilian/world 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 10.5% of the Brazilian/world 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 (1:1) 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 J/cm² 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 5.1. 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.

Eligibility criteria: Inclusion Criteria:

* both sexes
* chronic wounds originating from the neuropathic diabetic foot
* contaminated lesions
* total score obtained on the Bates-Jensen scale between 13 and 60
* who submits all requested exams

Exclusion Criteria:

* wounds with etiologies that are not related to the diabetic foot
* ischemic diabetic foot who has an ankle-brachial index with a value between 0.7 and 1.3.
* glycated hemoglobin greater than 8%.

Primary outcomes:
measure: Bates-Jensen Wound Assesment Tool
timeFrame: Before the intervention
measure: Bates-Jensen Wound Assesment Tool
timeFrame: First day after intervention
measure: Bates-Jensen scale
timeFrame: Third day after intervention
measure: Bates-Jensen scale
timeFrame: Fifth day after intervention
measure: Bates-Jensen scale
timeFrame: Tenth day after intervention
Secondary outcomes:
measure: Diabetes twenty-one instrument
timeFrame: Before the intervention
measure: Diabetes twenty-one instrument
timeFrame: First day after intervention
measure: Diabetes twenty-one instrument
timeFrame: Third day after intervention
measure: Diabetes twenty-one instrument
timeFrame: The fifth day after intervention
measure: Diabetes twenty-one instrument
timeFrame: Tenth day after intervention
measure: Wagner Scale
timeFrame: Before the intervention
measure: Wagner Scale
timeFrame: First day after intervention
measure: Wagner Scale
timeFrame: Third day after intervention
measure: Wagner Scale
timeFrame: Fifth day after intervention
measure: Wagner Scale
timeFrame: Tenth day after intervention
measure: WiFi scale
timeFrame: Before the intervention
measure: WiFi scale
timeFrame: First day after intervention
measure: WiFi scale
timeFrame: Third day after intervention
measure: WiFi scale
timeFrame: Fifth day after intervention
measure: WiFi scale
timeFrame: Tenth day after intervention
measure: Nursing Outcomes Classification Taxonomy
timeFrame: Before the intervention
measure: Nursing Outcomes Classification Taxonomy
timeFrame: First day after intervention
measure: Nursing Outcomes Classification Taxonomy
timeFrame: Third day after intervention
measure: Nursing Outcomes Classification Taxonomy
timeFrame: Fifth day after intervention
measure: Nursing Outcomes Classification Taxonomy
timeFrame: Tenth day after intervention
measure: Runtherford Scale for ischemia evaluation
timeFrame: Before the intervention
measure: Runtherford Scale for ischemia evaluation
timeFrame: First day after intervention
measure: Runtherford Scale for ischemia evaluation
timeFrame: Third day after intervention
measure: Runtherford Scale for ischemia evaluation
timeFrame: Fifth day after intervention
measure: Runtherford Scale for ischemia evaluation
timeFrame: Tenth day after intervention
measure: protective sensitivity of the feet through the monofilament
timeFrame: Before the intervention
measure: protective sensitivity of the feet through the monofilament
timeFrame: First day after intervention
measure: protective sensitivity of the feet through the monofilament
timeFrame: Third day after intervention
measure: protective sensitivity of the feet through the monofilament
timeFrame: Fifth day after intervention
measure: protective sensitivity of the feet through the monofilament
timeFrame: Tenth day after intervention
measure: protective sensitivity of the feet through tuning fork test
timeFrame: Before the intervention
measure: protective sensitivity of the feet through tuning fork test
timeFrame: First day after intervention
measure: protective sensitivity of the feet through tuning fork test
timeFrame: Third day after intervention
measure: protective sensitivity of the feet through tuning fork test
timeFrame: Fifth day after intervention
measure: protective sensitivity of the feet through tuning fork test
timeFrame: Tenth day after intervention
measure: Fontaine Classification
timeFrame: Before the intervention
measure: Fontaine Classification
timeFrame: First day after intervention
measure: Fontaine Classification
timeFrame: Third day after intervention
measure: Fontaine Classification
timeFrame: Fifth day after intervention
measure: Fontaine Classification
timeFrame: Tenth day after intervention
measure: Vibration Sensation
timeFrame: Before the intervention
measure: Vibration Sensation
timeFrame: First day after intervention
measure: Vibration Sensation
timeFrame: Third day after intervention
measure: Vibration Sensation
timeFrame: Fifth day after intervention
measure: Vibration Sensation
timeFrame: Tenth day after intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Raquel Agnelli Mesquita-Ferrari
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Raquel Agnelli Mesquita-Ferrari, PhD
role: STUDY_DIRECTOR
References: