Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Procedure: antimicrobial photodynamic therapy
- Registration Number
- NCT06416462
- Lead Sponsor
- University of Nove de Julho
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group control antimicrobial photodynamic therapy 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. experiment group antimicrobial photodynamic therapy 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.
- Primary Outcome Measures
Name Time Method Bates-Jensen scale Tenth day after 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, 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.
Bates-Jensen Wound Assesment Tool First day after 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.
- Secondary Outcome Measures
Name Time Method Diabetes twenty-one instrument Tenth day after intervention he Diabetes-21 (D-21) instrument evaluates the quality of life of individuals living with diabetes by assessing the physical, emotional, and social impacts of the condition. It consists of 21 items scored on a Likert scale, reflecting the intensity or frequency of diabetes-related challenges. The scoring ranges from a minimum of 21 to a maximum of 105. Lower scores indicate a better quality of life, suggesting fewer diabetes-related difficulties, while higher scores reflect a worse quality of life, indicating more significant challenges or negative impacts. This makes the D-21 a valuable tool for assessing the burden of diabetes in both clinical and research settings.
Wagner Scale Tenth day after intervention The Wagner Scale is a classification system used to evaluate the severity of diabetic foot ulcers. It categorizes ulcers based on depth, tissue involvement, and the presence of infection or gangrene. The scale ranges from 0 to 5, with higher scores indicating more severe conditions. A score of 0 represents a pre-ulcerative lesion or intact skin, while a score of 5 indicates extensive gangrene involving the entire foot. The Wagner Scale is widely used in clinical settings to guide treatment decisions and monitor the progression of diabetic foot complications.
WiFi scale Tenth day after intervention The WiFi scale is a classification system used to assess the severity of diabetic foot ulcers by evaluating three key factors: wound size and depth (W), ischemia (I), and foot infection (Fi). Each component is graded from 0 to 3, with higher grades indicating more severe conditions. The combined scores help determine the overall risk of amputation and guide treatment planning. A higher overall score indicates a worse prognosis and increased need for advanced interventions. The WiFi scale is widely used in clinical practice to stratify risk and optimize care for patients with diabetic foot complications.
Nursing Outcomes Classification Taxonomy Tenth day after intervention Assess skin integrity using the Nursing Outcomes Classification Taxonomy
Runtherford Scale for ischemia evaluation Tenth day after intervention Classification on the degree of ischemia, with some differences in the parameters assessed: asymptomatic (0); mild claudication (1); moderate claudication (2); severe claudication (3); ischemic pain at rest (4); minor tissue loss (5); major tissue loss (6). The higher value corresponds to the worst result.
protective sensitivity of the feet through the monofilament Tenth day after intervention The protective sensitivity test using a monofilament evaluates whether an individual can feel pressure on specific points of their feet. The outcome is classified as either the presence or absence of protective sensation.
protective sensitivity of the feet through tuning fork test Tenth day after intervention The protective sensitivity test using a tuning fork evaluates the ability to perceive vibration in specific points on the feet, typically at bony prominences. The outcome is classified as either the presence or absence of protective sensation.
Fontaine Classification Tenth day after intervention primarily rely on the degree of limb ischemia, evaluating the following parameters: asymptomatic (I); mild claudication (IIa); moderate to severe claudication (IIb); rest pain (III); gangrene or ulceration (IV).
Vibration Sensation Tenth day after intervention To assess vibratory sensitivity, a 128Hz tuning fork is applied to a bony area (e.g., elbow, clavicle, sternum, chin) to demonstrate the expected sensation. The participant then closes their eyes, and the tuning fork is applied with constant pressure to the dorsal side of the hallux's distal phalanx or another toe if the hallux is missing. If all phalanges are amputated, it's applied to the nearby area. The tuning fork is held in place until the participant reports the vibration has ceased. The test is repeated twice, with at least one "simulated" application where the tuning fork doesn't vibrate. A positive test result is when the participant correctly identifies vibration in at least two out of three applications, while a negative result is when they inaccurately identify vibration in two out of three applications, indicating a lack of vibratory sensitivity
Trial Locations
- Locations (1)
Raquel Agnelli Mesquita-Ferrari
🇧🇷São Paulo, SP, Brazil