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

Phase 2

Completed

Interventions: Procedure: Percutaneous Isolated Limb Perfusion (PILP) delivery
Drug: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment Group	Percutaneous Isolated Limb Perfusion (PILP) delivery	The Treatment Group received intravenous Timentin prior to their PILP procedure.
Treatment Group	Timentin	The Treatment Group received intravenous Timentin prior to their PILP procedure.
Control Group	Timentin	The Control Group received standard dosings of intravenous Timentin plus other standard care.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures