ID

20589

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00845897

Stichworte

Versionen (1)
  1. 05.03.17 05.03.17 -
Hochgeladen am

5. März 2017

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT00845897

Englisch

Eligibility Diabetes Mellitus NCT00845897

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Ambulatory

Datentyp

boolean

Alias
UMLS CUI [1]
C0439841
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection in the involved foot
Beschreibung

Communicable Disease Foot Involved

Datentyp

boolean

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

Injection of botulinum toxin

Datentyp

boolean

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

Ulcer Dorsum of foot Surface

Datentyp

boolean

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

Ankle brachial index

Datentyp

boolean

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

Cerebrovascular accident | Nervous system problem Complicating Rehabilitation

Datentyp

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.
Beschreibung

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

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
Beschreibung

Pharmacotherapy | Anticoagulants

Datentyp

boolean

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

Neuromuscular Diseases | Peripheral Neuropathy Due to Diabetes Mellitus

Datentyp

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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Ähnliche Modelle

Eligibility Diabetes Mellitus NCT00845897

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