ID

20578

Description

A Study of Intra-dermal Injection of Botulinum Toxin Type A for the Diabetic Neuropathic Foot Pain; ODM derived from: https://clinicaltrials.gov/show/NCT00336349

Link

https://clinicaltrials.gov/show/NCT00336349

Keywords

Versions (2)
  1. 3/4/17 3/4/17 -
  2. 3/4/17 3/4/17 -
Uploaded on

March 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Diabetes Mellitus NCT00336349

English

Eligibility Diabetes Mellitus NCT00336349

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. type 2 diabetes with medication for diabetes＞ 3 years (established diagnosis, hba1c<10% )
Description

Non-Insulin-Dependent Diabetes Mellitus Established diagnosis | Antidiabetics | Glycosylated hemoglobin A Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0332139
UMLS CUI [2]
C0935929
UMLS CUI [3,1]
C0019018
UMLS CUI [3,2]
C0439165
2. symptomatic polyneuropathy (stocking distribution and tingling pain)
Description

Polyneuropathy Symptomatic | NEUROPATHY PERIPHERAL STOCKING GLOVE | Pain tingling

Data type

boolean

Alias
UMLS CUI [1,1]
C0152025
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0746874
UMLS CUI [3,1]
C0030193
UMLS CUI [3,2]
C2242996
3. stable but not satisfactory effects of drugs for diabetic neuropathic foot pain (stable effects of medication for over 6 months)
Description

Foot pain Diabetic Neuropathy | Medication effects Stable | Medication effects Unsatisfactory

Data type

boolean

Alias
UMLS CUI [1,1]
C0016512
UMLS CUI [1,2]
C0011882
UMLS CUI [2,1]
C1319171
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C1319171
UMLS CUI [3,2]
C0439856
4. fitness of polyneuropathy on nerve conduction velocity (ncv) criteria
Description

Appropriateness Polyneuropathy Nerve Conduction velocity criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0814634
UMLS CUI [1,2]
C0152025
UMLS CUI [1,3]
C0429381
UMLS CUI [1,4]
C0243161
5. willing and able to give written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. willing and able to complete the entire study course and comply with study directions.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. injection not possible due to physiologic barriers.
Description

Unsuccessful injection Due to Limitation Physiological

Data type

boolean

Alias
UMLS CUI [1,1]
C0940893
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0449295
UMLS CUI [1,4]
C0205463
2. subject is pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. females of childbearing age who are not using a reliable method of avoiding pregnancy.
Description

Childbearing Potential Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205412
4. significant medical or psychiatric disease.
Description

Disease Significant | Mental disorder Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0750502
5. any condition that may put the subject at increased risk with exposure to botox®, including
Description

Risk Increase Botox Exposure to

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0442805
UMLS CUI [1,3]
C0700702
UMLS CUI [1,4]
C0332157
6. diagnosed myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
Description

Myasthenia Gravis Interferes with neuromuscular function | Lambert-Eaton syndrome Interferes with neuromuscular function | Amyotrophic Lateral Sclerosis Interferes with neuromuscular function | Disease Interferes with neuromuscular function

Data type

boolean

Alias
UMLS CUI [1,1]
C0026896
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0597053
UMLS CUI [2,1]
C3161080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0597053
UMLS CUI [3,1]
C0002736
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0597053
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0597053
7. use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
Description

Aminoglycoside Antibiotics Interfere with neuromuscular function | Curare-like Agents Interfere with neuromuscular function | Pharmaceutical Preparations Interfere with neuromuscular function

Data type

boolean

Alias
UMLS CUI [1,1]
C0003233
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0597053
UMLS CUI [2,1]
C0010464
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0597053
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0597053
8. acute medication overuse in the investigator's best judgment.
Description

Medication Overuse

Data type

boolean

Alias
UMLS CUI [1]
C3266697
9. alcohol or drug abuse.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
10. heavy smokers
Description

Heavy smoker

Data type

boolean

Alias
UMLS CUI [1]
C0857118
11. infection or skin problems at any of the injection sites.
Description

Communicable Disease Injection site | Skin problem Injection site

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2700396
UMLS CUI [2,1]
C0281822
UMLS CUI [2,2]
C2700396
12. known allergy or sensitivity to the study medications or its components.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Constituents

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0729650
13. injections of anesthetics or steroids into the study targeted muscles within one month prior to the day of injection
Description

Anesthetics Injection Muscles Targeted | Steroids Injection Muscles Targeted

Data type

boolean

Alias
UMLS CUI [1,1]
C0002932
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C0026845
UMLS CUI [1,4]
C1521840
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C1828121
UMLS CUI [2,3]
C0026845
UMLS CUI [2,4]
C1521840
14. concurrent participation in another clinical trial within 30 days of the beginning of this study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
15. previous use of botulinum toxin. (types a or b)
Description

Botulinum Toxin Type A | Botulinum toxin type B

Data type

boolean

Alias
UMLS CUI [1]
C0006050
UMLS CUI [2]
C0006051
16. profound atrophy or excessive weakness of the muscles in the target area(s) or injection.
Description

Target Area Muscular Atrophy Profound | Target Area Muscle Weakness Excessive | Target Area Injection

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0026846
UMLS CUI [1,4]
C0439808
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0205146
UMLS CUI [2,3]
C0151786
UMLS CUI [2,4]
C0442802
UMLS CUI [3,1]
C1521840
UMLS CUI [3,2]
C0205146
UMLS CUI [3,3]
C1533685
17. evidence of peripheral artery occlusion
Description

Peripheral artery occlusion Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C1112655
UMLS CUI [1,2]
C0332120
18. evidence of liver or renal function impairment
Description

Liver Dysfunction Evidence of | Renal Insufficiency Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0332120
19. evidence old stroke
Description

old stroke Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0850564
UMLS CUI [1,2]
C0332120
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Similar models

Eligibility Diabetes Mellitus NCT00336349

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Established diagnosis | Antidiabetics | Glycosylated hemoglobin A Percentage
Item
1. type 2 diabetes with medication for diabetes＞ 3 years (established diagnosis, hba1c<10% )
boolean
C0011860 (UMLS CUI [1,1])
C0332139 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2])
C0019018 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Polyneuropathy Symptomatic | NEUROPATHY PERIPHERAL STOCKING GLOVE | Pain tingling
Item
2. symptomatic polyneuropathy (stocking distribution and tingling pain)
boolean
C0152025 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0746874 (UMLS CUI [2])
C0030193 (UMLS CUI [3,1])
C2242996 (UMLS CUI [3,2])
Foot pain Diabetic Neuropathy | Medication effects Stable | Medication effects Unsatisfactory
Item
3. stable but not satisfactory effects of drugs for diabetic neuropathic foot pain (stable effects of medication for over 6 months)
boolean
C0016512 (UMLS CUI [1,1])
C0011882 (UMLS CUI [1,2])
C1319171 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C1319171 (UMLS CUI [3,1])
C0439856 (UMLS CUI [3,2])
Appropriateness Polyneuropathy Nerve Conduction velocity criteria
Item
4. fitness of polyneuropathy on nerve conduction velocity (ncv) criteria
boolean
C0814634 (UMLS CUI [1,1])
C0152025 (UMLS CUI [1,2])
C0429381 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Informed Consent
Item
5. willing and able to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
6. willing and able to complete the entire study course and comply with study directions.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Unsuccessful injection Due to Limitation Physiological
Item
1. injection not possible due to physiologic barriers.
boolean
C0940893 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0449295 (UMLS CUI [1,3])
C0205463 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
2. subject is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Inadequate
Item
3. females of childbearing age who are not using a reliable method of avoiding pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
Disease Significant | Mental disorder Significant
Item
4. significant medical or psychiatric disease.
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Risk Increase Botox Exposure to
Item
5. any condition that may put the subject at increased risk with exposure to botox®, including
boolean
C0035647 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
C0700702 (UMLS CUI [1,3])
C0332157 (UMLS CUI [1,4])
Myasthenia Gravis Interferes with neuromuscular function | Lambert-Eaton syndrome Interferes with neuromuscular function | Amyotrophic Lateral Sclerosis Interferes with neuromuscular function | Disease Interferes with neuromuscular function
Item
6. diagnosed myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
boolean
C0026896 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0597053 (UMLS CUI [1,3])
C3161080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0597053 (UMLS CUI [2,3])
C0002736 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0597053 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0597053 (UMLS CUI [4,3])
Aminoglycoside Antibiotics Interfere with neuromuscular function | Curare-like Agents Interfere with neuromuscular function | Pharmaceutical Preparations Interfere with neuromuscular function
Item
7. use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
boolean
C0003233 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0597053 (UMLS CUI [1,3])
C0010464 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0597053 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0597053 (UMLS CUI [3,3])
Medication Overuse
Item
8. acute medication overuse in the investigator's best judgment.
boolean
C3266697 (UMLS CUI [1])
Substance Use Disorders
Item
9. alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1])
Heavy smoker
Item
10. heavy smokers
boolean
C0857118 (UMLS CUI [1])
Communicable Disease Injection site | Skin problem Injection site
Item
11. infection or skin problems at any of the injection sites.
boolean
C0009450 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0281822 (UMLS CUI [2,1])
C2700396 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Constituents
Item
12. known allergy or sensitivity to the study medications or its components.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0729650 (UMLS CUI [2,3])
Anesthetics Injection Muscles Targeted | Steroids Injection Muscles Targeted
Item
13. injections of anesthetics or steroids into the study targeted muscles within one month prior to the day of injection
boolean
C0002932 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0026845 (UMLS CUI [1,3])
C1521840 (UMLS CUI [1,4])
C0038317 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0026845 (UMLS CUI [2,3])
C1521840 (UMLS CUI [2,4])
Study Subject Participation Status
Item
14. concurrent participation in another clinical trial within 30 days of the beginning of this study.
boolean
C2348568 (UMLS CUI [1])
Botulinum Toxin Type A | Botulinum toxin type B
Item
15. previous use of botulinum toxin. (types a or b)
boolean
C0006050 (UMLS CUI [1])
C0006051 (UMLS CUI [2])
Target Area Muscular Atrophy Profound | Target Area Muscle Weakness Excessive | Target Area Injection
Item
16. profound atrophy or excessive weakness of the muscles in the target area(s) or injection.
boolean
C1521840 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0026846 (UMLS CUI [1,3])
C0439808 (UMLS CUI [1,4])
C1521840 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C0151786 (UMLS CUI [2,3])
C0442802 (UMLS CUI [2,4])
C1521840 (UMLS CUI [3,1])
C0205146 (UMLS CUI [3,2])
C1533685 (UMLS CUI [3,3])
Peripheral artery occlusion Evidence of
Item
17. evidence of peripheral artery occlusion
boolean
C1112655 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Liver Dysfunction Evidence of | Renal Insufficiency Evidence of
Item
18. evidence of liver or renal function impairment
boolean
C0086565 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
old stroke Evidence of
Item
19. evidence old stroke
boolean
C0850564 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
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