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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
Sponsor:
Information provided by (Responsible Party):
Ilker Uckay, University Hospital, Geneva

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
Diabetic foot infections requiring tretement
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
  34.2%
38
  47.5%
65
  40.9%
>=65 years
52
  65.8%
42
  52.5%
94
  59.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 79 participants 80 participants 159 participants
70
(38 to 90)
67
(34 to 94)
68
(34 to 94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
Female
9
  11.4%
8
  10.0%
17
  10.7%
Male
70
  88.6%
72
  90.0%
142
  89.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 80 participants 159 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
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%
0
   0.0%
White
79
 100.0%
80
 100.0%
159
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Switzerland Number Analyzed 79 participants 80 participants 159 participants
79 80 159
1.Primary Outcome
Title Number of Participants Experiencing Clinical Failure
Hide Description Visual and dichotomous evaluation regarding the numbers of clinical recurrence/failure
Time Frame 30-60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short Antibiotic Arm Long Antibiotic Arm
Hide Arm/Group Description:
For soft tissue infection: 10 days of systemic antibiotics For osteomyelitis: 3 weeks
For soft tissue infections: 20 days For osteomyelitis: 6 weeks
Overall Number of Participants Analyzed 79 80
Measure Type: Number
Unit of Measure: Participants
26 30
2.Secondary Outcome
Title Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy
Hide Description Adverse events related to the antibiotic therapy.
Time Frame 30-60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Short Antibiotic Arm Long Antibiotic Arm
Hide Arm/Group Description:
For soft tissue infection: 10 days of systemic antibiotics For osteomyelitis: 3 weeks
For soft tissue infections: 20 days For osteomyelitis: 6 weeks
Overall Number of Participants Analyzed 79 80
Measure Type: Number
Unit of Measure: Participants
31 27
Time Frame The adverse events were collected during the first two months of therapy.
Adverse Event Reporting Description Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
 
Arm/Group Title Short Antibiotic Arm Long Antibiotic Arm
Hide Arm/Group Description 10 days antibiotic for soft tissue infections 3 weeks antibiotic for osteomyelitis 20 days antibiotic for soft tissue infections 6 weeks antibiotic for osteomyelitis
All-Cause Mortality
Short Antibiotic Arm Long Antibiotic Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)      0/80 (0.00%)    
Hide Serious Adverse Events
Short Antibiotic Arm Long Antibiotic Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/79 (6.33%)      6/80 (7.50%)    
General disorders     
Progressive ischemia leading to necrosis and amputation  [1]  5/79 (6.33%)  5 6/80 (7.50%)  6
Indicates events were collected by systematic assessment
[1]
Progressive ischemia leading to necrosis and amputation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Short Antibiotic Arm Long Antibiotic Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/79 (6.33%)      6/80 (7.50%)    
General disorders     
Cutaneous rash  [1]  5/79 (6.33%)  5 6/80 (7.50%)  6
Indicates events were collected by systematic assessment
[1]
Cutaneous rash
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Ilker UCKAY
Organization: Balgrist University Hospital
Phone: +41 44 386 37 05
EMail: ilker.uckay@balgrist.ch
Layout table for additonal information
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