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

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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:
Information provided by (Responsible Party):
Osprey Medical, Inc

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158442


Locations
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Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Osprey Medical, Inc
Investigators
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Principal Investigator: Paul Wraight, Assoc. Prof. Royal Melbourne Hospital, Head, Diabetic Foot Unit
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Responsible Party: Osprey Medical, Inc
ClinicalTrials.gov Identifier: NCT02158442    
Other Study ID Numbers: O-PILP-C01 - Part B
First Posted: June 6, 2014    Key Record Dates
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:
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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