Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot: Double Blind Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Bates-Jensen Wound Assesment Tool
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •glycated hemoglobin greater than 8%.
研究组 & 干预措施
Simulation of antimicroial Photodynamic therapy group
Participants in the control group will be treated in exactly the same way as the aPDT group, however the light treatment will be simulated. The device will be placed in position, however it will be switched off. After three weeks of monitoring in the control group, the patient will be informed that they were in the placebo group and will be offered treatment with aPDT and irradiation, for ethical reasons.
Antimicrobial Photodynamic therapy group
In the experimental group (aPDT), 1% methylene blue applied with the aid of a syringe will be used as a photosensitizer (with a pre-irradiation time of 5 minutes, 6 J of red laser will be applied.
干预措施: antimicrobial photodynamic therapy (Procedure)
结局指标
主要结局
Bates-Jensen Wound Assesment Tool
时间窗: Before the intervention
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Bates-Jensen Wound Assesment Tool
时间窗: Day after the first session
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Bates-Jensen scale
时间窗: Day after the third session
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Bates-Jensen scale
时间窗: Day after the fifth session
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5: minimum values indicate the best wound condition, maximum values represent the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with HIGHER scores indicating WORSE wound conditions.
Bates-Jensen scale
时间窗: Day after the tenth session
The Bates-Jensen Scale is an effective tool for wound assessment. In its current version, it includes 13 characteristics to be evaluated: size, depth, edges, undermining, type of necrotic tissue, amount of necrotic tissue, exudate type, exudate amount, skin color around the wound, perilesional tissue edema, perilesional tissue induration, granulation tissue, and epithelialization. Each item on the scale is scored from 1 to 5, where 1 indicates the best wound condition, and 5 represents the worst condition. The total score is obtained by summing all the items and can range from 13 to 65 points, with higher scores indicating worse wound conditions.
次要结局
- Nursing Outcomes Classification Taxonomy(Day after the tenth session)
- Diabetes twenty-one instrument(Before the intervention)
- Diabetes twenty-one instrument(Day after the first session)
- Diabetes twenty-one instrument(Day after the third session)
- Diabetes twenty-one instrument(Day after the fifth session)
- Diabetes twenty-one instrument(Day after the tenth session)
- Wagner Scale(Before the intervention)
- Wagner Scale(Day after the first session)
- Wagner Scale(Day after the third session)
- Wagner Scale(Day after the fifth session)
- Wagner Scale(Day after the tenth session)
- WiFi scale(Before the intervention)
- WiFi scale(Day after the first session)
- WiFi scale(Day after the third session)
- WiFi scale(Day after the fifth session)
- WiFi scale(Day after the tenth session)
- Nursing Outcomes Classification Taxonomy(Before the intervention)
- Nursing Outcomes Classification Taxonomy(Day after the first session)
- Nursing Outcomes Classification Taxonomy(Day after the third session)
- Nursing Outcomes Classification Taxonomy(Day after the fifth session)
- Runtherford Scale for ischemia evaluation(Before the intervention)
- Runtherford Scale for ischemia evaluation(Day after the first session)
- Runtherford Scale for ischemia evaluation(Day after the third session)
- Runtherford Scale for ischemia evaluation(Day after the fifth session)
- Runtherford Scale for ischemia evaluation(Day after the tenth session)
- protective sensitivity of the feet through the monofilament(Before the intervention)
- protective sensitivity of the feet through the monofilament(Day after the first session)
- protective sensitivity of the feet through the monofilament(Day after the third session)
- protective sensitivity of the feet through the monofilament(Day after the fifth session)
- protective sensitivity of the feet through the monofilament(Day after the tenth session)
- protective sensitivity of the feet through tuning fork test(Before the intervention)
- protective sensitivity of the feet through tuning fork test(Day after the first session)
- protective sensitivity of the feet through tuning fork test(Day after the third session)
- protective sensitivity of the feet through tuning fork test(Day after the fifth session)
- protective sensitivity of the feet through tuning fork test(Day after the tenth session)
- Fontaine Classification(Before the intervention)
- Fontaine Classification(Day after the first session)
- Fontaine Classification(Day after the third session)
- Fontaine Classification(Day after the fifth session)
- Fontaine Classification(Day after the tenth session)
- Vibration Sensation(Before the intervention)
- Vibration Sensation(Day after the first session)
- Vibration Sensation(Day after the third session)
- Vibration Sensation(Day after the fifth session)
- Vibration Sensation(Day after the tenth session)
研究者
Kristianne Porta Santos Fernandes
Clinical colaborator
University of Nove de Julho