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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Osprey Medical, Inc
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids; Ticarcillin; Ticarcillin-clavulanic acid

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