NCT02158442

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Osprey Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-02-01
• Completion: 2015-03-01
• First posted: 2014-06-06
• Last updated: 2016-09-30
• Results posted: 2016-08-03

Locations

1 site across 1 country: Australia