Diabetes, Infection
Conditions
Keywords
Diabetes, Lower limb infection, Significant wound infections, Intravenous antibiotics, Timentin
Brief summary
The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life.
Detailed description
During the PILP procedure, the circulation of the limb is isolated separately from the general circulatory system thereby enabling the delivery of antibiotics only to the limb. Limb isolation is achieved by creating an artificial circuit where catheters are inserted into the major artery and vein of the lower limb.
Interventions
PROCEDUREPercutaneous Isolated Limb Perfusion (PILP) delivery
The Percutaneous Isolated Limb Perfusion (PILP) delivery intervention procedure enables the use of existing antibiotic therapies in a more targeted and aggressive fashion; it addresses limitations associated with the use of conventional antibiotic drug delivery. As part of the procedure, the circulation of the limb is isolated separately from the general circulatory system enabling the delivery of antibiotic at high therapeutic doses that are not achievable when standard doses are administered intravenously.
DRUGTimentin
The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
Sponsors
Osprey Medical, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* M or F subjects 18 - 90 years old * Subject has pre-existing diabetes diagnosis * Subject has significant infection below the ankle of soft tissue and may include bone, and IV antibiotics are needed in order to salve limb or life * Consequence of infected wound would require Std of Care share debridement * Subject willing and able to provide written informed consent * Subject willing and able to comply with requirements of study protocol including pre-defined follow-up evaluations * PROCEDURAL INCLUSION CRITERIA: successful cannulation of the femoral artery and vein and placement of the venous support device
Exclusion criteria
* Allergy to contrast media * Known bleeding disorder including thrombocytopenia * Recent AMI or elevated Troponin levels within last 30 days * Penicillin sensitivity; Timentin sensitivity * Female subjects known to be or suspected to be pregnant or lactating * Subject unable to comply with instructions; especially to remain supine for duration of recirculation procedure * Subjects who have participated in any other clinical trial or taken investigational drug within 30 days of study enrollment * The PI determines the subject is not an appropriate subject for the study * PROCEDURAL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 3 | 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. |
Countries
Australia
Participant flow
Recruitment details
First subject enrolled 17 Oct 2013. Study completion 28 Feb 2015.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group The Treatment Group received intravenous Timentin prior to their PILP procedure. | 6 |
| Control Group The Control Group received standard dosings of intravenous Timentin plus other standard care. | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Perfusion staff not available | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Treatment Group | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 4 Participants | 3 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 6.8 | 64.2 years STANDARD_DEVIATION 8.3 | 63.0 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment Australia | 13 participants | 6 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 6 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 1 / 7 |
Outcome results
Primary
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.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group | 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 |
| Control Group | 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. | 3 participants |