ID

20578

Beschreibung

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

Stichworte

Versionen (2)
  1. 04.03.17 04.03.17 -
  2. 04.03.17 04.03.17 -
Hochgeladen am

4. März 2017

DOI

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Eligibility Diabetes Mellitus NCT00336349

Englisch

Eligibility Diabetes Mellitus NCT00336349

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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)
Beschreibung

Polyneuropathy Symptomatic | NEUROPATHY PERIPHERAL STOCKING GLOVE | Pain tingling

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Appropriateness Polyneuropathy Nerve Conduction velocity criteria

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

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

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Unsuccessful injection Due to Limitation Physiological

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

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.
Beschreibung

Childbearing Potential Contraceptive methods Inadequate

Datentyp

boolean

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

Disease Significant | Mental disorder Significant

Datentyp

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
Beschreibung

Risk Increase Botox Exposure to

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Medication Overuse

Datentyp

boolean

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

Substance Use Disorders

Datentyp

boolean

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

Heavy smoker

Datentyp

boolean

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

Communicable Disease Injection site | Skin problem Injection site

Datentyp

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.
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Constituents

Datentyp

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
Beschreibung

Anesthetics Injection Muscles Targeted | Steroids Injection Muscles Targeted

Datentyp

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.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

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

Botulinum Toxin Type A | Botulinum toxin type B

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Peripheral artery occlusion Evidence of

Datentyp

boolean

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

Liver Dysfunction Evidence of | Renal Insufficiency Evidence of

Datentyp

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
Beschreibung

old stroke Evidence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0850564
UMLS CUI [1,2]
C0332120
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Ähnliche Modelle

Eligibility Diabetes Mellitus NCT00336349

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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