ID

39079

Description

CSTC1 for Diabetic Foot Ulcers Phase II Study; ODM derived from: https://clinicaltrials.gov/show/NCT01813305

Link

https://clinicaltrials.gov/show/NCT01813305

Keywords

Versions (1)
  1. 11/28/19 11/28/19 -
Copyright Holder

See clinicaltrials.gov

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November 28, 2019

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Creative Commons BY 4.0
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Eligibility Diabetic Foot Ulcer NCT01813305

English

Eligibility Diabetic Foot Ulcer NCT01813305

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
with either gender aged at least 20 years old;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
with a diabetic ulcer (which is defined as the target ulcer) on the foot and not healing for at least 2 weeks;
Description

Diabetic foot ulcer Not healing Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1456868
UMLS CUI [1,2]
C3845448
UMLS CUI [1,3]
C0449238
the target ulcer is classified as grade 1 or 2 ulcer according to modified wagner system;
Description

Target Ulcer Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0041582
UMLS CUI [1,3]
C0441800
the target ulcer should show "infection control" at investigator's discretion;
Description

Target Ulcer Infection control

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0041582
UMLS CUI [1,3]
C0085557
subject should be free of any necrosis or infection in soft and bone tissue;
Description

Soft tissue necrosis Free of | Soft Tissue Infection Free of | Bone Tissue Necrosis Free of | Bone Tissue Infection Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C1561230
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0149778
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C0391978
UMLS CUI [3,2]
C0027540
UMLS CUI [3,3]
C0332296
UMLS CUI [4,1]
C0391978
UMLS CUI [4,2]
C3714514
UMLS CUI [4,3]
C0332296
subject has signed the written informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
with active osteomyelitis;
Description

Osteomyelitis

Data type

boolean

Alias
UMLS CUI [1]
C0029443
with target ulcer size decreased by at least 50% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before randomization visit;
Description

Target Ulcer Size Decreased | Status post Standard of Care

Data type

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0041582
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C0205216
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C2936643
with poor nutritional status (albumin < 3g/dl), poor diabetic control (hba1c > 12%), anemia (hemoglobin<10 g/dl), a leukocyte counts < 1,000/mm3, abnormal liver function (ast, alt>3 x upper limit of normal range);
Description

Nutritional status Poor | Albumin measurement | Diabetic - poor control | Hemoglobin A1c measurement | Anemia | Hemoglobin measurement | White Blood Cell Count procedure | Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0392209
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0201838
UMLS CUI [3]
C0421258
UMLS CUI [4]
C0474680
UMLS CUI [5]
C0002871
UMLS CUI [6]
C0518015
UMLS CUI [7]
C0023508
UMLS CUI [8]
C0086565
UMLS CUI [9]
C0151904
UMLS CUI [10]
C0151905
requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents;
Description

Patient need for Adrenal Cortex Hormones | Patient need for Immunosuppressive Agents | Patient need for Chemotherapeutic agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0001617
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0021081
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0003392
presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
Description

Necrosis | Purulence | Inflammatory sinus tract | Debridement Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C0027540
UMLS CUI [2]
C0854358
UMLS CUI [3]
C0544791
UMLS CUI [4,1]
C0011079
UMLS CUI [4,2]
C1272705
receiving revascularization surgery performed <8 weeks before entry in the study;
Description

Revascularization

Data type

boolean

Alias
UMLS CUI [1]
C0581603
with known or suspected hypersensitivity to any ingredients of study product and vehicle;
Description

Hypersensitivity Investigational New Drug Ingredient | Hypersensitivity Suspected Investigational New Drug Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C1550600
with coronary heart disease with myocardial infarction, coronary artery bypass graft (cabg), or percutaneous transluminal coronary angioplasty (ptca) within 3 months prior to study;
Description

Coronary heart disease | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty

Data type

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0010055
UMLS CUI [4]
C2936173
pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period;
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
enrollment in any investigational drug trial within 4 weeks before entering this study;
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
with any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject.
Description

Illness Uncontrolled | Study Subject Participation Status Unfavorable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C3640815
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Similar models

Eligibility Diabetic Foot Ulcer NCT01813305

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
with either gender aged at least 20 years old;
boolean
C0001779 (UMLS CUI [1])
Diabetic foot ulcer Not healing Duration
Item
with a diabetic ulcer (which is defined as the target ulcer) on the foot and not healing for at least 2 weeks;
boolean
C1456868 (UMLS CUI [1,1])
C3845448 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Target Ulcer Grade
Item
the target ulcer is classified as grade 1 or 2 ulcer according to modified wagner system;
boolean
C1521840 (UMLS CUI [1,1])
C0041582 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Target Ulcer Infection control
Item
the target ulcer should show "infection control" at investigator's discretion;
boolean
C1521840 (UMLS CUI [1,1])
C0041582 (UMLS CUI [1,2])
C0085557 (UMLS CUI [1,3])
Soft tissue necrosis Free of | Soft Tissue Infection Free of | Bone Tissue Necrosis Free of | Bone Tissue Infection Free of
Item
subject should be free of any necrosis or infection in soft and bone tissue;
boolean
C1561230 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0149778 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0391978 (UMLS CUI [3,1])
C0027540 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0391978 (UMLS CUI [4,1])
C3714514 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Informed Consent
Item
subject has signed the written informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Osteomyelitis
Item
with active osteomyelitis;
boolean
C0029443 (UMLS CUI [1])
Target Ulcer Size Decreased | Status post Standard of Care
Item
with target ulcer size decreased by at least 50% after at least 2 weeks of standard-of-care-only period or any other recorded regular therapy before randomization visit;
boolean
C1521840 (UMLS CUI [1,1])
C0041582 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0205216 (UMLS CUI [1,4])
C0231290 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
Nutritional status Poor | Albumin measurement | Diabetic - poor control | Hemoglobin A1c measurement | Anemia | Hemoglobin measurement | White Blood Cell Count procedure | Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
with poor nutritional status (albumin < 3g/dl), poor diabetic control (hba1c > 12%), anemia (hemoglobin<10 g/dl), a leukocyte counts < 1,000/mm3, abnormal liver function (ast, alt>3 x upper limit of normal range);
boolean
C0392209 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0201838 (UMLS CUI [2])
C0421258 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
C0002871 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0023508 (UMLS CUI [7])
C0086565 (UMLS CUI [8])
C0151904 (UMLS CUI [9])
C0151905 (UMLS CUI [10])
Patient need for Adrenal Cortex Hormones | Patient need for Immunosuppressive Agents | Patient need for Chemotherapeutic agents
Item
requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents;
boolean
C0686904 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0021081 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0003392 (UMLS CUI [3,2])
Necrosis | Purulence | Inflammatory sinus tract | Debridement Unsuccessful
Item
presence of necrosis, purulence or sinus tracts that cannot be removed by debridement;
boolean
C0027540 (UMLS CUI [1])
C0854358 (UMLS CUI [2])
C0544791 (UMLS CUI [3])
C0011079 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
Revascularization
Item
receiving revascularization surgery performed <8 weeks before entry in the study;
boolean
C0581603 (UMLS CUI [1])
Hypersensitivity Investigational New Drug Ingredient | Hypersensitivity Suspected Investigational New Drug Ingredient
Item
with known or suspected hypersensitivity to any ingredients of study product and vehicle;
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1550600 (UMLS CUI [2,4])
Coronary heart disease | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty
Item
with coronary heart disease with myocardial infarction, coronary artery bypass graft (cabg), or percutaneous transluminal coronary angioplasty (ptca) within 3 months prior to study;
boolean
C0010068 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs
Item
enrollment in any investigational drug trial within 4 weeks before entering this study;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Illness Uncontrolled | Study Subject Participation Status Unfavorable
Item
with any uncontrolled illness judged by the investigator that entering the trial may be detrimental to the subject.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C3640815 (UMLS CUI [2,2])
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