ID

36562

Description

Nutritional Regulation of Wound Inflammation: Part III; ODM derived from: https://clinicaltrials.gov/show/NCT02332993

Link

https://clinicaltrials.gov/show/NCT02332993

Keywords

Versions (1)
  1. 5/21/19 5/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Negative Pressure Therapy NCT02332993

English

Eligibility Negative Pressure Therapy NCT02332993

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 30 - 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient must understand and give written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient must be a type ii diabetic
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c ≤9%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
receiving negative pressure therapy (npwt)
Description

Negative-Pressure Wound Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1956078
one or more of the following:
Description

Inclusion criteria Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1265611
transcutaneous oxygen measurement >30 mmhg
Description

Cutaneous Oximetry

Data type

boolean

Alias
UMLS CUI [1]
C0040656
abi (ankle-brachial index) >0.7 and less 1.3
Description

Ankle brachial pressure index

Data type

boolean

Alias
UMLS CUI [1]
C1328319
toe pressures >30 mmhg
Description

Toe Blood Pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0040357
UMLS CUI [1,2]
C0005823
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
individuals who are deemed unable to understand the procedures, risks and benefits of the study, i.e. informed consent will be excluded.
Description

Study Protocol Comprehension Unable | Informed Consent Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0332196
patients who are pregnant (all women of childbearing age will have a urine hcg test upon enrollment and agree upon one of the following forms of contraception for the duration of the study: abstinence, hormonal contraception, spermicidal condoms, or either you or your partner having been surgically sterilized)
Description

Pregnancy | Childbearing Potential Urine hCG pregnancy test | Childbearing Potential Contraceptive methods | Sexual Abstinence | Hormonal contraception | Condoms | Spermatocidal Agents | Female Sterilization | Male sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C2188702
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0036899
UMLS CUI [5]
C2985296
UMLS CUI [6]
C0677582
UMLS CUI [7]
C0037862
UMLS CUI [8]
C0015787
UMLS CUI [9]
C0024559
immuno-compromised patients; receiving radiation therapy, chemo, or have gone through transplantation or other conditions with prolonged steroid use
Description

Immunocompromised patient | Therapeutic radiology procedure | Chemotherapy | Transplantation | Steroid use Prolonged

Data type

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0040732
UMLS CUI [5,1]
C0281991
UMLS CUI [5,2]
C0439590
patients with clinical signs of soft tissue infection such as fever, erythema, leukocytosis, purulent drainage.
Description

Sign or Symptom Soft Tissue Infection | Fever | Erythema | Leukocytosis | Purulent drainage

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0149778
UMLS CUI [2]
C0015967
UMLS CUI [3]
C0041834
UMLS CUI [4]
C0023518
UMLS CUI [5]
C0517630
antibiotic use 7 days prior to biopsy and cultures
Description

Antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C0003232
current smoker
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
clinically significant kidney or liver disease (dialysis)
Description

Kidney Disease | Liver disease | Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0011946
severe neurologic dysfunction
Description

Neurologic Dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0751377
UMLS CUI [1,2]
C0205082
females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize potential of confounders.
Description

Pregnancy | Immunocompromised patient

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0085393
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Similar models

Eligibility Negative Pressure Therapy NCT02332993

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients 30 - 70 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
patient must understand and give written informed consent
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
patient must be a type ii diabetic
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≤9%
boolean
C0474680 (UMLS CUI [1])
Negative-Pressure Wound Therapy
Item
receiving negative pressure therapy (npwt)
boolean
C1956078 (UMLS CUI [1])
Inclusion criteria Quantity
Item
one or more of the following:
boolean
C1512693 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Cutaneous Oximetry
Item
transcutaneous oxygen measurement >30 mmhg
boolean
C0040656 (UMLS CUI [1])
Ankle brachial pressure index
Item
abi (ankle-brachial index) >0.7 and less 1.3
boolean
C1328319 (UMLS CUI [1])
Toe Blood Pressure
Item
toe pressures >30 mmhg
boolean
C0040357 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Protocol Comprehension Unable | Informed Consent Excluded
Item
individuals who are deemed unable to understand the procedures, risks and benefits of the study, i.e. informed consent will be excluded.
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Pregnancy | Childbearing Potential Urine hCG pregnancy test | Childbearing Potential Contraceptive methods | Sexual Abstinence | Hormonal contraception | Condoms | Spermatocidal Agents | Female Sterilization | Male sterilization
Item
patients who are pregnant (all women of childbearing age will have a urine hcg test upon enrollment and agree upon one of the following forms of contraception for the duration of the study: abstinence, hormonal contraception, spermicidal condoms, or either you or your partner having been surgically sterilized)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C2188702 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4])
C2985296 (UMLS CUI [5])
C0677582 (UMLS CUI [6])
C0037862 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
C0024559 (UMLS CUI [9])
Immunocompromised patient | Therapeutic radiology procedure | Chemotherapy | Transplantation | Steroid use Prolonged
Item
immuno-compromised patients; receiving radiation therapy, chemo, or have gone through transplantation or other conditions with prolonged steroid use
boolean
C0085393 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0040732 (UMLS CUI [4])
C0281991 (UMLS CUI [5,1])
C0439590 (UMLS CUI [5,2])
Sign or Symptom Soft Tissue Infection | Fever | Erythema | Leukocytosis | Purulent drainage
Item
patients with clinical signs of soft tissue infection such as fever, erythema, leukocytosis, purulent drainage.
boolean
C3540840 (UMLS CUI [1,1])
C0149778 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
C0041834 (UMLS CUI [3])
C0023518 (UMLS CUI [4])
C0517630 (UMLS CUI [5])
Antibiotics
Item
antibiotic use 7 days prior to biopsy and cultures
boolean
C0003232 (UMLS CUI [1])
Tobacco use
Item
current smoker
boolean
C0543414 (UMLS CUI [1])
Kidney Disease | Liver disease | Dialysis
Item
clinically significant kidney or liver disease (dialysis)
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Neurologic Dysfunction Severe
Item
severe neurologic dysfunction
boolean
C0751377 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnancy | Immunocompromised patient
Item
females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize potential of confounders.
boolean
C0032961 (UMLS CUI [1])
C0085393 (UMLS CUI [2])
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