ID

20589

Description

Botulinum Toxin Effects on Plantar Ulcer Recurrence; ODM derived from: https://clinicaltrials.gov/show/NCT00845897

Link

https://clinicaltrials.gov/show/NCT00845897

Keywords

Versions (1)
  1. 3/5/17 3/5/17 -
Uploaded on

March 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00845897

English

Eligibility Diabetes Mellitus NCT00845897

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of diabetes mellitus and determination of diminished or absent plantar sensation
Description

Diabetes Mellitus | decreased tactile sensation plantar | Sensation-absent plantar

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C2164434
UMLS CUI [2,2]
C0230463
UMLS CUI [3,1]
C3842091
UMLS CUI [3,2]
C0230463
a recurrent forefoot plantar ulcer; at least the second occurrence of a plantar ulcer or a previous failure to heal a plantar ulcer with reasonable treatment intervention (total contact casting, off loading boot, molded ankle foot orthotic, gillette, or therapeutic footwear modifications)
Description

Plantar Ulcer Recurrent Forefoot | Plantar Ulcer Occurrence Quantity | Plantar Ulcer Interventional procedure failed | Orthopedic casting Foot | Foot pressure off loading device | orthotics lower limb ankle-foot molded | Footwear Modification Therapeutic

Data type

boolean

Alias
UMLS CUI [1,1]
C0086815
UMLS CUI [1,2]
C2945760
UMLS CUI [1,3]
C1510667
UMLS CUI [2,1]
C0086815
UMLS CUI [2,2]
C2745955
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0086815
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C0231175
UMLS CUI [4,1]
C2014382
UMLS CUI [4,2]
C0016504
UMLS CUI [5]
C1971399
UMLS CUI [6]
C2014801
UMLS CUI [7,1]
C0336894
UMLS CUI [7,2]
C0392747
UMLS CUI [7,3]
C0302350
ambulatory
Description

Ambulatory

Data type

boolean

Alias
UMLS CUI [1]
C0439841
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection in the involved foot
Description

Communicable Disease Foot Involved

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0016504
UMLS CUI [1,3]
C1314939
previous botulinum toxin injections
Description

Injection of botulinum toxin

Data type

boolean

Alias
UMLS CUI [1]
C1321035
ulcers on the dorsal surface of the foot
Description

Ulcer Dorsum of foot Surface

Data type

boolean

Alias
UMLS CUI [1,1]
C0041582
UMLS CUI [1,2]
C0230462
UMLS CUI [1,3]
C0205148
ankle-brachial index <0.45
Description

Ankle brachial index

Data type

boolean

Alias
UMLS CUI [1]
C1328319
history of cerebral vascular accident or other neurological problems complicating their rehabilitation
Description

Cerebrovascular accident | Nervous system problem Complicating Rehabilitation

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0221571
UMLS CUI [2,2]
C1522701
UMLS CUI [2,3]
C0034991
women of childbearing years unless pregnancy test is agreed upon, completed, and negative and agree to use some form of contraception during the study.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
current drug therapy that includes an anticoagulant
Description

Pharmacotherapy | Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0003280
history of a neuromuscular disease, except peripheral neuropathy as a result of diabetes mellitus
Description

Neuromuscular Diseases | Peripheral Neuropathy Due to Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0027868
UMLS CUI [2,1]
C0031117
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0011849
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Similar models

Eligibility Diabetes Mellitus NCT00845897

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus | decreased tactile sensation plantar | Sensation-absent plantar
Item
diagnosis of diabetes mellitus and determination of diminished or absent plantar sensation
boolean
C0011849 (UMLS CUI [1])
C2164434 (UMLS CUI [2,1])
C0230463 (UMLS CUI [2,2])
C3842091 (UMLS CUI [3,1])
C0230463 (UMLS CUI [3,2])
Plantar Ulcer Recurrent Forefoot | Plantar Ulcer Occurrence Quantity | Plantar Ulcer Interventional procedure failed | Orthopedic casting Foot | Foot pressure off loading device | orthotics lower limb ankle-foot molded | Footwear Modification Therapeutic
Item
a recurrent forefoot plantar ulcer; at least the second occurrence of a plantar ulcer or a previous failure to heal a plantar ulcer with reasonable treatment intervention (total contact casting, off loading boot, molded ankle foot orthotic, gillette, or therapeutic footwear modifications)
boolean
C0086815 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C1510667 (UMLS CUI [1,3])
C0086815 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0086815 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C2014382 (UMLS CUI [4,1])
C0016504 (UMLS CUI [4,2])
C1971399 (UMLS CUI [5])
C2014801 (UMLS CUI [6])
C0336894 (UMLS CUI [7,1])
C0392747 (UMLS CUI [7,2])
C0302350 (UMLS CUI [7,3])
Ambulatory
Item
ambulatory
boolean
C0439841 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Foot Involved
Item
active infection in the involved foot
boolean
C0009450 (UMLS CUI [1,1])
C0016504 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Injection of botulinum toxin
Item
previous botulinum toxin injections
boolean
C1321035 (UMLS CUI [1])
Ulcer Dorsum of foot Surface
Item
ulcers on the dorsal surface of the foot
boolean
C0041582 (UMLS CUI [1,1])
C0230462 (UMLS CUI [1,2])
C0205148 (UMLS CUI [1,3])
Ankle brachial index
Item
ankle-brachial index <0.45
boolean
C1328319 (UMLS CUI [1])
Cerebrovascular accident | Nervous system problem Complicating Rehabilitation
Item
history of cerebral vascular accident or other neurological problems complicating their rehabilitation
boolean
C0038454 (UMLS CUI [1])
C0221571 (UMLS CUI [2,1])
C1522701 (UMLS CUI [2,2])
C0034991 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of childbearing years unless pregnancy test is agreed upon, completed, and negative and agree to use some form of contraception during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Pharmacotherapy | Anticoagulants
Item
current drug therapy that includes an anticoagulant
boolean
C0013216 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
Neuromuscular Diseases | Peripheral Neuropathy Due to Diabetes Mellitus
Item
history of a neuromuscular disease, except peripheral neuropathy as a result of diabetes mellitus
boolean
C0027868 (UMLS CUI [1])
C0031117 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,3])
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