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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | The Treatment Group received intravenous Timentin prior to their PILP procedure. |
|
| Control Group | Active Comparator | The Control Group received standard dosings of intravenous Timentin plus other standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Isolated Limb Perfusion (PILP) delivery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Wraight, Assoc. Prof. | Royal Melbourne Hospital, Head, Diabetic Foot Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
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First subject enrolled 17 Oct 2013. Study completion 28 Feb 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | The Treatment Group received intravenous Timentin prior to their PILP procedure. |
| FG001 | Control Group | The Control Group received standard dosings of intravenous Timentin plus other standard care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | The Treatment Group received intravenous Timentin prior to their PILP procedure. |
| BG001 | Control Group | The Control Group received standard dosings of intravenous Timentin plus other standard care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Treatment Group: 5 of the 5 analyzable microbiological loads resulted in a reduction. 1 was not analyzable. Control Group: 3 of the 3 analyzable microbiological loads resulted in a reduction. 4 were not analyzable. | Posted | Number | participants | Day 3 |
|
Through 28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | The Treatment Group received intravenous Timentin prior to their PILP procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MCA Infarct | Cardiac disorders | Non-systematic Assessment | R MCA Infarct on control subject |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Shepard | Osprey Medical | 952.955.8236 | mshepard@ospreymed.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007239 | Infections |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D036801 | Parturition |
| C043215 | ticarcillin-clavulanic acid |
| D013982 | Ticarcillin |
| D019818 | Clavulanic Acid |
| ID | Term |
|---|---|
| D011247 | Pregnancy |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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|
| Timentin | Drug | The Control Group will receive standard dosings of intravenous Timentin plus other standard care. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | The Control Group received standard dosings of intravenous Timentin plus other standard care. |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control Group | The Control Group received standard dosings of intravenous Timentin plus other standard care. | 1 | 7 | 0 | 7 |
|
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| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002969 | Clavulanic Acids |