Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot

Diabetic Foot Ulcer Clinical Trial

Official title:

Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot: Double Blind Randomized Controlled Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416462
• Other study ID #: 6.296.354
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: University of Nove de Julho
• Contact: Raquel Agnelli Mesquita-Ferrari, PhD
• Phone: +55 (11) 2633-9000
• Email: raquel.mesquita[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Procedure:
• antimicrobial photodynamic therapy
When starting the research, all wounds, regardless of the study group, will be cleaned with 0.9% saline solution (SF0.9%), using a 40x12 needle and a 500ml bottle of SF0.9%, in order to maintain pressure. for equal cleaning of all wounds and a hydrofiber plate with silver was used as standard coverage. Experimental group (n=45): When starting the intervention, all services in both groups will follow the cleaning standard described previously. In the aPDT group, 1% methylene blue will be used as a photosensitizer applied with the aid of a syringe (with a pre-irradiation time of 5 minutes), 6 J of laser will be applied.

Locations

Country	Name	City	State
Brazil	Raquel Agnelli Mesquita-Ferrari	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bates-Jensen Wound Assesment Tool	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.	Before the intervention
Primary	Bates-Jensen Wound Assesment Tool	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.	First day after intervention
Primary	Bates-Jensen scale	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.	Third day after intervention
Primary	Bates-Jensen scale	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.	Fifth day after intervention
Primary	Bates-Jensen scale	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.	Tenth day after intervention
Secondary	Diabetes-21 instrument	Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument	Before the intervention
Secondary	Diabetes-21 instrument	Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument	First day after intervention
Secondary	Diabetes-21 instrument	Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument	Third day after intervention
Secondary	Diabetes-21 instrument	Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument	The fifth day after intervention
Secondary	Diabetes-21 instrument	Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument	Tenth day after intervention
Secondary	Wagner Scale	Classify the diabetic foot wound with the Wagner Scale	Before the intervention
Secondary	Wagner Scale	Classify the diabetic foot wound with the Wagner Scale	First day after intervention
Secondary	Wagner Scale	Classify the diabetic foot wound with the Wagner Scale	Third day after intervention
Secondary	Wagner Scale	Classify the diabetic foot wound with the Wagner Scale	Fifth day after intervention
Secondary	Wagner Scale	Classify the diabetic foot wound with the Wagner Scale	Tenth day after intervention
Secondary	WiFi scale	Assess the risk of amputation using the WiFi scale	Before the intervention
Secondary	WiFi scale	Assess the risk of amputation using the WiFi scale	First day after intervention
Secondary	WiFi scale	Assess the risk of amputation using the WiFi scale	Third day after intervention
Secondary	WiFi scale	Assess the risk of amputation using the WiFi scale	Fifth day after intervention
Secondary	WiFi scale	Assess the risk of amputation using the WiFi scale	Tenth day after intervention
Secondary	Nursing Outcomes Classification Taxonomy	Assess skin integrity using the Nursing Outcomes Classification Taxonomy	Before the intervention
Secondary	Nursing Outcomes Classification Taxonomy	Assess skin integrity using the Nursing Outcomes Classification Taxonomy	First day after intervention
Secondary	Nursing Outcomes Classification Taxonomy	Assess skin integrity using the Nursing Outcomes Classification Taxonomy	Third day after intervention
Secondary	Nursing Outcomes Classification Taxonomy	Assess skin integrity using the Nursing Outcomes Classification Taxonomy	Fifth day after intervention
Secondary	Nursing Outcomes Classification Taxonomy	Assess skin integrity using the Nursing Outcomes Classification Taxonomy	Tenth day after intervention
Secondary	Runtherford Scale for ischemia evaluation	Rutherford et al. (1997) also base their 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.	Before the intervention
Secondary	Runtherford Scale for ischemia evaluation	Rutherford et al. (1997) also base their 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.	First day after intervention
Secondary	Runtherford Scale for ischemia evaluation	Rutherford et al. (1997) also base their 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.	Third day after intervention
Secondary	Runtherford Scale for ischemia evaluation	Rutherford et al. (1997) also base their 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.	Fifth day after intervention
Secondary	Runtherford Scale for ischemia evaluation	Rutherford et al. (1997) also base their 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.	Tenth day after intervention
Secondary	protective sensitivity of the feet	Assess the protective sensitivity of the feet through the monofilament and tuning fork test	Before the intervention
Secondary	protective sensitivity of the feet	Assess the protective sensitivity of the feet through the monofilament and tuning fork test	First day after intervention
Secondary	protective sensitivity of the feet	Assess the protective sensitivity of the feet through the monofilament and tuning fork test	Third day after intervention
Secondary	protective sensitivity of the feet	Assess the protective sensitivity of the feet through the monofilament and tuning fork test	Fifth day after intervention
Secondary	protective sensitivity of the feet	Assess the protective sensitivity of the feet through the monofilament and tuning fork test	Tenth day after intervention
Secondary	Fontaine Classification	Fontaine et al. (1957) 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).	Before the intervention
Secondary	Fontaine Classification	Fontaine et al. (1957) 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).	First day after intervention
Secondary	Fontaine Classification	Fontaine et al. (1957) 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).	Third day after intervention
Secondary	Fontaine Classification	Fontaine et al. (1957) 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).	Fifth day after intervention
Secondary	Fontaine Classification	Fontaine et al. (1957) 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).	Tenth day after intervention
Secondary	Vibration Sensation	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 (IWGDF, 2019).	Before the intervention
Secondary	Vibration Sensation	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 (IWGDF, 2019).	First day after intervention
Secondary	Vibration Sensation	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 (IWGDF, 2019).	Third day after intervention
Secondary	Vibration Sensation	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 (IWGDF, 2019).	Fifth day after intervention
Secondary	Vibration Sensation	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 (IWGDF, 2019).	Tenth day after intervention