- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416462
Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot
Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot: Double Blind Randomized Controlled Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raquel Agnelli Mesquita-Ferrari, PhD
- Phone Number: +55 (11) 2633-9000
- Email: raquel.mesquita@gmail.com
Study Locations
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SP
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São Paulo, SP, Brazil, 11030-480
- Raquel Agnelli Mesquita-Ferrari
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Contact:
- Raquel R Agnelli Mesquita-Ferrari
- Email: annacrth@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: group control
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.
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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.
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Active Comparator: experiment 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bates-Jensen Wound Assesment Tool
Time Frame: 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. |
Before the intervention
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Bates-Jensen Wound Assesment Tool
Time Frame: 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. |
First day after intervention
|
Bates-Jensen scale
Time Frame: Third 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. |
Third day after intervention
|
Bates-Jensen scale
Time Frame: Fifth 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. |
Fifth day after intervention
|
Bates-Jensen scale
Time Frame: 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.
|
Tenth day after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes-21 instrument
Time Frame: Before the intervention
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Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument
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Before the intervention
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Diabetes-21 instrument
Time Frame: First day after intervention
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Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument
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First day after intervention
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Diabetes-21 instrument
Time Frame: Third day after intervention
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Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument
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Third day after intervention
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Diabetes-21 instrument
Time Frame: The fifth day after intervention
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Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument
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The fifth day after intervention
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Diabetes-21 instrument
Time Frame: Tenth day after intervention
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Evaluate the effect of aPDT on quality of life using the Diabetes-21 instrument
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Tenth day after intervention
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Wagner Scale
Time Frame: Before the intervention
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Classify the diabetic foot wound with the Wagner Scale
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Before the intervention
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Wagner Scale
Time Frame: First day after intervention
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Classify the diabetic foot wound with the Wagner Scale
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First day after intervention
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Wagner Scale
Time Frame: Third day after intervention
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Classify the diabetic foot wound with the Wagner Scale
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Third day after intervention
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Wagner Scale
Time Frame: Fifth day after intervention
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Classify the diabetic foot wound with the Wagner Scale
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Fifth day after intervention
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Wagner Scale
Time Frame: Tenth day after intervention
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Classify the diabetic foot wound with the Wagner Scale
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Tenth day after intervention
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WiFi scale
Time Frame: Before the intervention
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Assess the risk of amputation using the WiFi scale
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Before the intervention
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WiFi scale
Time Frame: First day after intervention
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Assess the risk of amputation using the WiFi scale
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First day after intervention
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WiFi scale
Time Frame: Third day after intervention
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Assess the risk of amputation using the WiFi scale
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Third day after intervention
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WiFi scale
Time Frame: Fifth day after intervention
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Assess the risk of amputation using the WiFi scale
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Fifth day after intervention
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WiFi scale
Time Frame: Tenth day after intervention
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Assess the risk of amputation using the WiFi scale
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Tenth day after intervention
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Nursing Outcomes Classification Taxonomy
Time Frame: Before the intervention
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Assess skin integrity using the Nursing Outcomes Classification Taxonomy
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Before the intervention
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Nursing Outcomes Classification Taxonomy
Time Frame: First day after intervention
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Assess skin integrity using the Nursing Outcomes Classification Taxonomy
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First day after intervention
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Nursing Outcomes Classification Taxonomy
Time Frame: Third day after intervention
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Assess skin integrity using the Nursing Outcomes Classification Taxonomy
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Third day after intervention
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Nursing Outcomes Classification Taxonomy
Time Frame: Fifth day after intervention
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Assess skin integrity using the Nursing Outcomes Classification Taxonomy
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Fifth day after intervention
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Nursing Outcomes Classification Taxonomy
Time Frame: Tenth day after intervention
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Assess skin integrity using the Nursing Outcomes Classification Taxonomy
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Tenth day after intervention
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Runtherford Scale for ischemia evaluation
Time Frame: Before the intervention
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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.
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Before the intervention
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Runtherford Scale for ischemia evaluation
Time Frame: First day after intervention
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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
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Runtherford Scale for ischemia evaluation
Time Frame: Third day after intervention
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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.
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Third day after intervention
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Runtherford Scale for ischemia evaluation
Time Frame: Fifth day after intervention
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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.
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Fifth day after intervention
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Runtherford Scale for ischemia evaluation
Time Frame: Tenth day after intervention
|
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.
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Tenth day after intervention
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protective sensitivity of the feet
Time Frame: Before the intervention
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Assess the protective sensitivity of the feet through the monofilament and tuning fork test
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Before the intervention
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protective sensitivity of the feet
Time Frame: First day after intervention
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Assess the protective sensitivity of the feet through the monofilament and tuning fork test
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First day after intervention
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protective sensitivity of the feet
Time Frame: Third day after intervention
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Assess the protective sensitivity of the feet through the monofilament and tuning fork test
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Third day after intervention
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protective sensitivity of the feet
Time Frame: Fifth day after intervention
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Assess the protective sensitivity of the feet through the monofilament and tuning fork test
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Fifth day after intervention
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protective sensitivity of the feet
Time Frame: Tenth day after intervention
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Assess the protective sensitivity of the feet through the monofilament and tuning fork test
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Tenth day after intervention
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Fontaine Classification
Time Frame: Before the intervention
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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).
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Before the intervention
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Fontaine Classification
Time Frame: First day after intervention
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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).
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First day after intervention
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Fontaine Classification
Time Frame: Third day after intervention
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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).
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Third day after intervention
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Fontaine Classification
Time Frame: Fifth day after intervention
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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).
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Fifth day after intervention
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Fontaine Classification
Time Frame: Tenth day after intervention
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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
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Vibration Sensation
Time Frame: Before the intervention
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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).
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Before the intervention
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Vibration Sensation
Time Frame: First day after intervention
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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).
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First day after intervention
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Vibration Sensation
Time Frame: Third 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 (IWGDF, 2019).
|
Third day after intervention
|
Vibration Sensation
Time Frame: Fifth 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 (IWGDF, 2019).
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Fifth day after intervention
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Vibration Sensation
Time Frame: 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 (IWGDF, 2019).
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Tenth day after intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Raquel Agnelli Mesquita-Ferrari, PhD, University of Nove de Julho
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6.296.354
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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