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

NCT02158442 | Completed Phase 2 Results

• 1 other identifier: O-PILP-C01 - Part B
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Infection

Keywords

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

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Procedure: Percutaneous Isolated Limb Perfusion (PILP) delivery; Drug: Timentin

Control Group

ACTIVE COMPARATOR

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

Drug: Timentin

Interventions

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.

Treatment Group

Timentin DRUG

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

Also known as: Ticarcillin and Clavulanate

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known severe proximal femoral artery vascular disease precluding placement of perfusion catheters

Sponsors & Collaborators

• Osprey Medical, Inc: lead

Study Sites (1)

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Infections

Interventions

Parturition; ticarcillin-clavulanic acid; Ticarcillin; Clavulanic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids

Results Point of Contact

• Title: Michele Shepard
• Organization: Osprey Medical

mshepard@ospreymed.com

952.955.8236

Study Officials

• Paul Wraight, Assoc. Prof.

  Royal Melbourne Hospital, Head, Diabetic Foot Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: June 6, 2014
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 30, 2016
• Results First Posted: August 3, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)