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

Primary Purpose

Diabetes, Infection

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Percutaneous Isolated Limb Perfusion (PILP) delivery

Timentin

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Lower limb infection, Significant wound infections, Intravenous antibiotics, Timentin

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

The Treatment Group received intravenous Timentin prior to their PILP procedure.

The Control Group received standard dosings of intravenous Timentin plus other standard care.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02158442

First Posted

April 11, 2014

Last Updated

August 23, 2016

Sponsor

Osprey Medical, Inc

1. Study Identification

Unique Protocol Identification Number

NCT02158442

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Osprey Medical, Inc

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

The Treatment Group received intravenous Timentin prior to their PILP procedure.

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

The Control Group received standard dosings of intravenous Timentin plus other standard care.

Intervention Type

Procedure

Intervention Name(s)

Percutaneous Isolated Limb Perfusion (PILP) delivery

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Timentin

Other Intervention Name(s)

Ticarcillin and Clavulanate

Intervention Description

The Control Group will receive standard dosings of intravenous Timentin plus other standard care.

Primary Outcome Measure Information:

Title

Description

Time Frame

Day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Wraight, Assoc. Prof.

Organizational Affiliation

Royal Melbourne Hospital, Head, Diabetic Foot Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Melbourne Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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