Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients
Condition: Diabetes; Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Percutaneous Isolated Limb Perfusion (PILP) delivery; Timentin
Intervention description: 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.; The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
Intervention MeSH terms: Clavulanic Acid; Ticarcillin-clavulanic acid; Ticarcillin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Diabetes; Lower limb infection; Significant wound infections; Intravenous antibiotics; Timentin

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.
    

Eligibility criteria:

        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