Clinical trial NCT02158442: Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Infection
Keywords: Diabetes
Lower limb infection
Significant wound infections
Intravenous antibiotics
Timentin
Lead sponsor: Osprey Medical, Inc
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Royal Melbourne Hospital, Head, Diabetic Foot Unit
name: Paul Wraight, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: