Trial Outcomes & Findings for Less Infections for the Diabetic Foot (NCT NCT03615807)
NCT ID: NCT03615807
Last Updated: 2020-06-09
Results Overview
Visual and dichotomous evaluation regarding the numbers of clinical recurrence/failure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
182 participants
Primary outcome timeframe
30-60 days
Results posted on
2020-06-09
Participant Flow
Participant milestones
| Measure |
Short Antibiotic Arm
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
|
Standard Antibiotic Arm
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
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
91
|
|
Overall Study
COMPLETED
|
79
|
80
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Less Infections for the Diabetic Foot
Baseline characteristics by cohort
| Measure |
Short Antibiotic Arm
n=79 Participants
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
|
Standard Antibiotic Arm
n=80 Participants
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
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Age, Continuous
|
70 years
n=99 Participants
|
67 years
n=107 Participants
|
68 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
79 participants
n=99 Participants
|
80 participants
n=107 Participants
|
159 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30-60 daysVisual and dichotomous evaluation regarding the numbers of clinical recurrence/failure
Outcome measures
| Measure |
Short Antibiotic Arm
n=79 Participants
For soft tissue infection: 10 days of systemic antibiotics For osteomyelitis: 3 weeks
|
Long Antibiotic Arm
n=80 Participants
For soft tissue infections: 20 days For osteomyelitis: 6 weeks
|
|---|---|---|
|
Number of Participants Experiencing Clinical Failure
|
26 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 30-60 daysAdverse events related to the antibiotic therapy.
Outcome measures
| Measure |
Short Antibiotic Arm
n=79 Participants
For soft tissue infection: 10 days of systemic antibiotics For osteomyelitis: 3 weeks
|
Long Antibiotic Arm
n=80 Participants
For soft tissue infections: 20 days For osteomyelitis: 6 weeks
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events Related to the Antibiotic Therapy
|
31 Participants
|
27 Participants
|
Adverse Events
Short Antibiotic Arm
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Long Antibiotic Arm
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Short Antibiotic Arm
n=79 participants at risk
10 days antibiotic for soft tissue infections 3 weeks antibiotic for osteomyelitis
|
Long Antibiotic Arm
n=80 participants at risk
20 days antibiotic for soft tissue infections 6 weeks antibiotic for osteomyelitis
|
|---|---|---|
|
General disorders
Progressive ischemia leading to necrosis and amputation
|
6.3%
5/79 • Number of events 5 • The adverse events were collected during the first two months of therapy.
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.
|
7.5%
6/80 • Number of events 6 • The adverse events were collected during the first two months of therapy.
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.
|
Other adverse events
| Measure |
Short Antibiotic Arm
n=79 participants at risk
10 days antibiotic for soft tissue infections 3 weeks antibiotic for osteomyelitis
|
Long Antibiotic Arm
n=80 participants at risk
20 days antibiotic for soft tissue infections 6 weeks antibiotic for osteomyelitis
|
|---|---|---|
|
General disorders
Cutaneous rash
|
6.3%
5/79 • Number of events 5 • The adverse events were collected during the first two months of therapy.
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.
|
7.5%
6/80 • Number of events 6 • The adverse events were collected during the first two months of therapy.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place