Trial Outcomes & Findings for Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients (NCT NCT02158442)

Last Updated: 2016-09-30

Results Overview

Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the efficacy of Timentin delivered by PILP procedure (Treatment Group) versus intravenous delivery (Control Group) at reducing microbiological load in subjects with diabetes, and significant wound infection of the lower limb.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Day 3

Results posted on

2016-09-30

Participant Flow

First subject enrolled 17 Oct 2013. Study completion 28 Feb 2015.

Participant milestones

Participant milestones
Measure	Treatment Group The Treatment Group received intravenous Timentin prior to their PILP procedure.	Control Group The Control Group received standard dosings of intravenous Timentin plus other standard care.
Overall Study STARTED	8	7
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group The Treatment Group received intravenous Timentin prior to their PILP procedure.	Control Group The Control Group received standard dosings of intravenous Timentin plus other standard care.
Overall Study Withdrawal by Subject	1	0
Overall Study Perfusion staff not available	1	0

Baseline Characteristics

Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=6 Participants The Treatment Group received intravenous Timentin prior to their PILP procedure.	Control Group n=7 Participants The Control Group received standard dosings of intravenous Timentin plus other standard care.	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	64.2 years STANDARD_DEVIATION 8.3 • n=5 Participants	63.0 years STANDARD_DEVIATION 5.9 • n=7 Participants	63.5 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Australia	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3

Population: Treatment Group: 5 of the 5 analyzable microbiological loads resulted in a reduction. 1 was not analyzable. Control Group: 3 of the 3 analyzable microbiological loads resulted in a reduction. 4 were not analyzable.

Outcome measures

Outcome measures
Measure	Treatment Group n=5 Participants The Treatment Group received intravenous Timentin prior to their PILP procedure.	Control Group n=3 Participants The Control Group received standard dosings of intravenous Timentin plus other standard care.
Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.	5 participants	3 participants

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=6 participants at risk The Treatment Group received intravenous Timentin prior to their PILP procedure.	Control Group n=7 participants at risk The Control Group received standard dosings of intravenous Timentin plus other standard care.
Cardiac disorders MCA Infarct	0.00% 0/6 • Through 28 days.	14.3% 1/7 • Number of events 1 • Through 28 days.

Other adverse events

Adverse event data not reported

Additional Information

Michele Shepard

Osprey Medical

Phone: 952.955.8236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place