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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Study Comparing Clinical and Microbiological Efficacy of Timentin Delivered Via Percutaneous Isolated Limb Perfusion (PILP) or Intravenous Infusion in Diabetic Subjects With Moderate to Severe Lower Limb Infection

Conditions
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Diabetes, Infection

Intervention / Treatment
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* Procedure: Percutaneous Isolated Limb Perfusion (PILP) delivery
* Drug: Timentin


Participation Criteria
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Eligibility Criteria
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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 EXCLUSION CRITERIA: Subjects anatomy interferes with or is expected to prohibit successful cannulation of the femoral vessels or placement of the venous support device Known severe proximal femoral artery vascular disease precluding placement of perfusion catheters

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>The Treatment Group received intravenous Timentin prior to their PILP procedure. | Procedure: Percutaneous Isolated Limb Perfusion (PILP) delivery<br>* 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.<br>Drug: Timentin<br>* The Control Group will receive standard dosings of intravenous Timentin plus other standard care.<br>* Other names: Ticarcillin and Clavulanate;|
| Active Comparator: Control Group<br>The Control Group received standard dosings of intravenous Timentin plus other standard care. | Drug: Timentin<br>* The Control Group will receive standard dosings of intravenous Timentin plus other standard care.<br>* Other names: Ticarcillin and Clavulanate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Timentin, Diabetes, Lower limb infection, Significant wound infections, Intravenous antibiotics