ID

23195

Description

Responsible Party: Doerthe Seidel, Interim Scientific Leader of the Centre for Clinical Trials and Innovation, University of Witten/Herdecke ClinicalTrials.gov Identifier: NCT01480362 History of Changes Other Study ID Numbers: UWT_1_GKV DRKS00003347 ( Registry Identifier: German Clinical Trials Register ) Study First Received: November 23, 2011 Last Updated: April 22, 2016 Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds (DiaFu) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01480362

Link

https://clinicaltrials.gov/ct2/show/NCT01480362

Keywords

Versions (1)
  1. 6/27/17 6/27/17 -
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June 27, 2017

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License

Creative Commons BY 4.0
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Eligibility Diabetic Foot Wounds DRKS00003347 NCT01480362 DRKS00003347

English

Eligibility Diabetic Foot Wounds NCT01480362 DRKS00003347

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Presence of diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
Presence of a foot wound (chronic wounds; amputation wounds) Wagner stage 2-4
Description

Wagner Stage

Data type

boolean

Alias
UMLS CUI [1]
C0149697
Existence of the foot wound for at least 4 weeks
Description

Foot Wound: Length

Data type

boolean

Alias
UMLS CUI [1,1]
C0149697
UMLS CUI [1,2]
C0872146
Signed informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Patient's eligibility of NPWT in the opinion of the treating physician
Description

Negative Pressure Wound Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1956078
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
Age <18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Non-Compliance
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Allergies regarding the release of substances from components of each treatment arm
Description

Hypersensitivity to Study Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
Severe anemia, wich was not caused by an infection
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
Simultaneous participation of patients in another interventional study / previous participation in the same study
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Use of NPWT systems to the study-related foot lesion within a period of 6 weeks prior to study inclusion
Description

Previous Negative Pressure Wound Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C1956078
Presence of necrotic tissue with eschar, which can not be removed
Description

Necrotic tissue

Data type

boolean

Alias
UMLS CUI [1]
C2321738
Untreated osteitis or osteomyelitis
Description

Osteitis or osteomyelitis

Data type

boolean

Alias
UMLS CUI [1]
C0029400
UMLS CUI [2]
C0029443
Not examined / unexplored fistula
Description

Fistula

Data type

boolean

Alias
UMLS CUI [1]
C0016169
Malignancy of the wound
Description

Malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Exposed: nerves, blood vessels, anastomotic site
Description

Site of Lesion

Data type

boolean

Alias
UMLS CUI [1]
C0449695
ambulant NPWT of patients receiving anticoagulants (especially heparinization or marcumar therapy) or with otherwise highly impaired clotting function, which have a risk of circulatory relevant bleeding
Description

Bleeding Risk

Data type

boolean

Alias
UMLS CUI [1]
C3251812
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Similar models

Eligibility Diabetic Foot Wounds NCT01480362 DRKS00003347

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Diabetes Mellitus
Item
Presence of diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Wagner Stage
Item
Presence of a foot wound (chronic wounds; amputation wounds) Wagner stage 2-4
boolean
C0149697 (UMLS CUI [1])
Foot Wound: Length
Item
Existence of the foot wound for at least 4 weeks
boolean
C0149697 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Informed Consent
Item
Signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Negative Pressure Wound Therapy
Item
Patient's eligibility of NPWT in the opinion of the treating physician
boolean
C1956078 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Age
Item
Age <18 years
boolean
C0001779 (UMLS CUI [1])
Compliance
Item
Non-Compliance
boolean
C1321605 (UMLS CUI [1])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity to Study Drug
Item
Allergies regarding the release of substances from components of each treatment arm
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Anemia
Item
Severe anemia, wich was not caused by an infection
boolean
C0002871 (UMLS CUI [1])
Study Participation Status
Item
Simultaneous participation of patients in another interventional study / previous participation in the same study
boolean
C2348568 (UMLS CUI [1])
Previous Negative Pressure Wound Therapy
Item
Use of NPWT systems to the study-related foot lesion within a period of 6 weeks prior to study inclusion
boolean
C0205156 (UMLS CUI [1,1])
C1956078 (UMLS CUI [1,2])
Necrotic tissue
Item
Presence of necrotic tissue with eschar, which can not be removed
boolean
C2321738 (UMLS CUI [1])
Osteitis or osteomyelitis
Item
Untreated osteitis or osteomyelitis
boolean
C0029400 (UMLS CUI [1])
C0029443 (UMLS CUI [2])
Fistula
Item
Not examined / unexplored fistula
boolean
C0016169 (UMLS CUI [1])
Malignancy
Item
Malignancy of the wound
boolean
C0006826 (UMLS CUI [1])
Site of Lesion
Item
Exposed: nerves, blood vessels, anastomotic site
boolean
C0449695 (UMLS CUI [1])
Bleeding Risk
Item
ambulant NPWT of patients receiving anticoagulants (especially heparinization or marcumar therapy) or with otherwise highly impaired clotting function, which have a risk of circulatory relevant bleeding
boolean
C3251812 (UMLS CUI [1])
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