An interventional study of Educational and home-based physical therapy by foot-related exercises in Diabetic Neuropathies, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
A randomized controlled trial will be performed with 48 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the booklet for 8-weeks.
The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 8weeks, for all outcomes; and 16 weeks, for follow-up reasons for all outcomes.
The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) tactile and vibration sensititivity (10-g monofilament and tuning fork), (4) foot-ankle kinematics and ankle kinetics during gait (infrared cameras and inverse dynamics, respectively), (5) foot isometric strength (by a pressure plate measurement), (6) functional balance reach test, (7) foot health and functionality by the Foot Health Status Questionnaire, (8) plantar pressure distribution during gait.
The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 08-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.
629 studies on the registry are indexed under Diabetic Neuropathies; 92 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 522 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →University of Sao Paulo General Hospital is the lead sponsor of 608 studies on the registry; 97 are open to participants now.
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Exclusion Criteria:
Patients in the intervention group will perform foot-related exercises described in an educational booklet three times/week at home. In the follow-up period, patients will follow the same schedule set by the project till the end of the study (16-weeks).
Other: Educational and home-based physical therapy by foot-related exercises
Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus.
The booklet is divided in 2: educational and exercise protocol. The aim of the first part is to guide the individual for a change in his/her health behavior, and comprises info about diabetic neuropathy, foot care, shoes, and benefits of exercising. The second part is the foot protocol, composed by 6 exercises. The maximum duration of a session is 20min and should be performed 3 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the booklet, filling a table with the effort perceived (effort likert scale). The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression, which is also registered by the participant in the monthly table at the booklet.
Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
Time frame: 8-weeks
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
Time frame: 8-weeks
Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up)
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
Time frame: 16-weeks (Follow-up)
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up)
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
Time frame: 16-weeks (Follow-up)
Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks
Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.
Time frame: 8-weeks
Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks
Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations
Time frame: 8-weeks
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks
A pressure platform (emed®-q100, GmbH, Novel Munich, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: Heel peak pressure (kPa)
Time frame: 8-weeks
Change From Baseline Tactile Sensitivity at 8-weeks
Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.
Time frame: 8-weeks
Change From Baseline Vibration Sensitivity at 8-weeks
The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.
Time frame: 8-weeks
Change From Baseline Foot Health and Functionality at 8-weeks
The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. The domain assessed was function that receives a score from 0 to 100, where 100 expresses the best function and 0 to worst.
Time frame: 8-weeks
Change From Baseline Foot Isometric Strength at 8-weeks
The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (Novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux peak values of maximum force (% of bodyweight).
Time frame: 8-weeks
Change From Baseline Functional Balance at 8-weeks
It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance
Time frame: 8-weeks
Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up)
Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.
Time frame: 16-weeks (Follow-up)
Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up)
Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations
Time frame: 16-weeks (Follow-up)
Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up)
A pressure platform (emed®-q100, GmbH, Novel Munich, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: Heel peak pressure (kPa)
Time frame: 16-weeks (Follow-up)
Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up)
Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.
Time frame: 16-weeks (Follow-up)
Change From Baseline Vibration Sensitivity at 16-weeks (Follow-up)
The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.
Time frame: 16-weeks (follow-up)
Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up)
The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. The domain assessed was function and it receives a score from 0 to 100, where 100 expresses the best function and 0 to worst.
Time frame: 16-weeks (Follow-up)
Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up)
The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (Novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux peak values of maximum force (% of bodyweight).
Time frame: 16-weeks (Follow-up)
Change From Baseline Functional Balance at 16-weeks (Follow-up)
It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance
Time frame: 16-weeks (Follow-up)
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 25 | 25 |
| Completed | 18 | 20 |
| Not completed | 7 | 5 |
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Diabetic Neuropathy Symptoms at 8-weeks | 5.3 ± 0.5 | 6.2 ± 0.6 |
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
| score of a scale (0 to 10) | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 8-weeks | 3.7 ± 0.5 | 3.3 ± 0.5 |
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy).
| score of a scale (0 to 13) | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Diabetic Neuropathy Symptoms at 16-weeks (Follow-up) | 5.6 ± 0.5 | 6.0 ± 0.6 |
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture (LaBIMPH) available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
| score of a scale (0 to 10) | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 16-weeks (Follow-up) | 3.9 ± 0.6 | 3.6 ± 0.4 |
Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.
| degrees | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline of the Foot and Ankle Kinematics During Gait at 8-weeks | 23.7 ± 0.8 | 22.7 ± 0.8 |
Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations
| N*m/kg | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline of the Foot and Ankle Kinetics During Gait at 8-weeks | 1.3 ± 0.1 | 1.2 ± 0.1 |
A pressure platform (emed®-q100, GmbH, Novel Munich, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: Heel peak pressure (kPa)
| kPa | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 8-weeks | 338.2 ± 19.0 | 402.4 ± 21.2 |
Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.
| Number of insentitive foot areas | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Tactile Sensitivity at 8-weeks | 0 (0 to 1) | 0 (0 to 2) |
The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.
| Participants | Intervention Group | Control Group |
|---|---|---|
| absent - L R | 12 | 11 |
| reduced - L R | 11 | 9 |
The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. The domain assessed was function that receives a score from 0 to 100, where 100 expresses the best function and 0 to worst.
| score on a scale (0 to 100) | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Foot Health and Functionality at 8-weeks | 37.0 ± 6.1 | 36.3 ± 5.1 |
The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (Novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux peak values of maximum force (% of bodyweight).
| % bodyweight | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Foot Isometric Strength at 8-weeks | 13.8 ± 1.1 | 11.6 ± 1.3 |
It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance
| cm | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Functional Balance at 8-weeks | 25.7 ± 1.3 | 25.5 ± 1.3 |
Sagital plane of ankle range of motion - initial of dorsiflexion until the end of plantaflexion (degrees) during stance phase of gait.
| degrees | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline of the Foot and Ankle Kinematics During Gait at 16-weeks (Follow-up) | 24.6 ± 0.9 | 24.6 ± 0.8 |
Peak joint moment of ankle plantarflexor moment at push off during stance phase of gait by inverse dynamic calculations
| N*m/kg | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline of the Foot and Ankle Kinetics During Gait at 16-weeks (Follow-up) | 1.20 ± 0.05 | 1.25 ± 0.03 |
A pressure platform (emed®-q100, GmbH, Novel Munich, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: Heel peak pressure (kPa)
| kPa | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Dynamic Plantar Pressure Distribution During Gait at 16-weeks (Follow-up) | 339.9 ± 15.7 | 378.4 ± 22.7 |
Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.
| Number of insentitive foot areas | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Tactile Sensitivity at 16-weeks (Follow-up) | 0 (0 to 0) | 0 (0 to 1) |
The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.
| Participants | Intervention Group | Control Group |
|---|---|---|
| absent - L R | 6 | 2 |
| reduced - L R | 15 | 15 |
The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. The domain assessed was function and it receives a score from 0 to 100, where 100 expresses the best function and 0 to worst.
| score on a scale (0 to 100) | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Foot Health and Functionality at 16-weeks (Follow-up) | 40.3 ± 4.9 | 42.6 ± 6.2 |
The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (Novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux peak values of maximum force (% of bodyweight).
| % bodyweight | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Foot Isometric Strength at 16-weeks (Follow-up) | 13.1 ± 1.3 | 12.0 ± 1.2 |
It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance
| cm | Intervention Group | Control Group |
|---|---|---|
| Change From Baseline Functional Balance at 16-weeks (Follow-up) | 26.0 ± 1.1 | 22.9 ± 1.1 |
Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Control Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 59.1 ± 6.4 | 56.5 ± 9.4 | 57.8 ± 7.9 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 19 | 20 | 39 |
| Male | 6 | 5 | 11 |
| Race and Ethnicity Not Collected(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Brazil | 25 | 25 | 50 |
| Type 2 Diabetes(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Count of participants | 22 | 19 | 41 |
| Time of onset of diabetes(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 13.8 ± 10 | 18.2 ± 9.8 | 16 ± 9.9 |
| DPN symptoms - Michigan Neuropathy Screening Instrument(score on a scale) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 5.4 ± 1.9 | 6.9 ± 2.1 | 6.2 ± 1.6 |
| Fuzzy classification of the DPN severity(units on a scale) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 4.4 ± 2.6 | 4.9 ± 2.2 | 4.6 ± 2.4 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from May 2019 to primary completion in May 2021, 24 months.
Results were first posted in Sep 2024, 3 years 4 months after primary completion.
Of 150 non-industry interventional studies with no phase under Diabetic Neuropathies, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 24 months is above that.
Counting every sponsor, half of 167 studies reached it within 12 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital →