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

• ClinicalTrials.gov Identifier: NCT02158442
• Recruitment Status: Completed
• First Posted: June 6, 2014
• Results First Posted: August 3, 2016
• Last Update Posted: September 30, 2016
• Sponsor: Osprey Medical, Inc
• Information provided by (Responsible Party): Osprey Medical, Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes; Infection	Procedure: Percutaneous Isolated Limb Perfusion (PILP) delivery; Drug: Timentin	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: October 2013
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Group; The Treatment Group received intravenous Timentin prior to their PILP procedure.	Procedure: Percutaneous 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.; Drug: Timentin; The Control Group will receive standard dosings of intravenous Timentin plus other standard care.; Other Name: Ticarcillin and Clavulanate
Active Comparator: Control Group; The Control Group received standard dosings of intravenous Timentin plus other standard care.	Drug: Timentin; The Control Group will receive standard dosings of intravenous Timentin plus other standard care.; Other Name: Ticarcillin and Clavulanate

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Australia, Victoria

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Sponsors and Collaborators

Osprey Medical, Inc

Investigators

• Principal Investigator: Paul Wraight, Assoc. Prof.; Royal Melbourne Hospital, Head, Diabetic Foot Unit

More Information

• Responsible Party: Osprey Medical, Inc
• ClinicalTrials.gov Identifier: NCT02158442
• Other Study ID Numbers: O-PILP-C01 - Part B
• First Posted: June 6, 2014
• Results First Posted: August 3, 2016
• Last Update Posted: September 30, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Osprey Medical, Inc:

Diabetes; Lower limb infection; Significant wound infections; Intravenous antibiotics; Timentin

Additional relevant MeSH terms:

Infection; Communicable Diseases; Clavulanic Acid; Ticarcillin-clavulanic acid; Ticarcillin; beta-Lactamase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Bacterial Agents; Anti-Infective Agents