Less Infections for the Diabetic Foot
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ClinicalTrials.gov Identifier: NCT03615807 |
Recruitment Status :
Completed
First Posted : August 6, 2018
Results First Posted : June 1, 2020
Last Update Posted : June 9, 2020
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Diabetic Foot |
Interventions |
Procedure: Surgical debridement (if needed) Diagnostic Test: Microbiological sampling Procedure: Revascularisation (if needed). Device: Off-loading Behavioral: Patient's education and instructions Procedure: Wound debridement Drug: Antibiotic duration |
Enrollment | 182 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Short Antibiotic Arm | Standard Antibiotic Arm |
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10 days for soft tissue infections 3 weeks for osteomyelitis Surgical debridement (if needed): Surgical debridement Microbiological sampling: Microbiological sampling Revascularisation (if needed).: Revascularisation (if needed). Off-loading: Off-loading by Special shoes Patient's education and instructions: Patient's education and instructions by specialized nurses Wound debridement: Regular wound debridement by specialized nurses Antibiotic duration: Systemic antibiotic duration according to the study arms |
20 days for soft tissue infections 6 weeks for osteomyelitis Surgical debridement (if needed): Surgical debridement Microbiological sampling: Microbiological sampling Revascularisation (if needed).: Revascularisation (if needed). Off-loading: Off-loading by Special shoes Patient's education and instructions: Patient's education and instructions by specialized nurses Wound debridement: Regular wound debridement by specialized nurses Antibiotic duration: Systemic antibiotic duration according to the study arms |
Period Title: Overall Study | ||
Started | 91 | 91 |
Completed | 79 | 80 |
Not Completed | 12 | 11 |
Arm/Group Title | Short Antibiotic Arm | Standard Antibiotic Arm | Total | |
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10 days for soft tissue infections 3 weeks for osteomyelitis Surgical debridement (if needed): Surgical debridement Microbiological sampling: Microbiological sampling Revascularisation (if needed).: Revascularisation (if needed). Off-loading: Off-loading by Special shoes Patient's education and instructions: Patient's education and instructions by specialized nurses Wound debridement: Regular wound debridement by specialized nurses Antibiotic duration: Systemic antibiotic duration according to the study arms |
20 days for soft tissue infections 6 weeks for osteomyelitis Surgical debridement (if needed): Surgical debridement Microbiological sampling: Microbiological sampling Revascularisation (if needed).: Revascularisation (if needed). Off-loading: Off-loading by Special shoes Patient's education and instructions: Patient's education and instructions by specialized nurses Wound debridement: Regular wound debridement by specialized nurses Antibiotic duration: Systemic antibiotic duration according to the study arms |
Total of all reporting groups | |
Overall Number of Baseline Participants | 79 | 80 | 159 | |
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Diabetic foot infections requiring tretement
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | 80 participants | 159 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
27 34.2%
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38 47.5%
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65 40.9%
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>=65 years |
52 65.8%
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42 52.5%
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94 59.1%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 79 participants | 80 participants | 159 participants | |
70
(38 to 90)
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67
(34 to 94)
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68
(34 to 94)
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | 80 participants | 159 participants | |
Female |
9 11.4%
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8 10.0%
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17 10.7%
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Male |
70 88.6%
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72 90.0%
|
142 89.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | 80 participants | 159 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
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0 0.0%
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Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
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0 0.0%
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White |
79 100.0%
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80 100.0%
|
159 100.0%
|
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Switzerland | Number Analyzed | 79 participants | 80 participants | 159 participants |
79 | 80 | 159 |
Name/Title: | Professor Ilker UCKAY |
Organization: | Balgrist University Hospital |
Phone: | +41 44 386 37 05 |
EMail: | ilker.uckay@balgrist.ch |
Responsible Party: | Ilker Uckay, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT03615807 |
Other Study ID Numbers: |
n° 2016-01008 |
First Submitted: | January 16, 2017 |
First Posted: | August 6, 2018 |
Results First Submitted: | April 8, 2020 |
Results First Posted: | June 1, 2020 |
Last Update Posted: | June 9, 2020 |