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Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

Information source: Innocoll
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Foot Ulcer, Diabetic; Infection

Intervention: Gentamicin collagen sponge (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Innocoll

Official(s) and/or principal investigator(s):
James Tursi, MD, Study Director, Affiliation: Chief Medical Officer, Innocoll

Overall contact:
Lisa Hemsen, Phone: (860) 620-9201, Email: lhemsen@innocollinc.com

Summary

This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2: 1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.

Clinical Details

Official title: A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With an Infected Foot Ulcer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Cure (Resolution of all clinical signs and symptoms of infection)

Secondary outcome:

Clinical cure and Baseline pathogen eradication (Resolution of all clinical signs and symptoms of infection) and baseline pathogen eradication)

Reinfection (Percent of patients with re-infection)

Time to Clinical Cure

Amputation (Percent of patients that have an amputation associated with the target ulcer)

Ulcer closure (Percent of patients with target ulcer closure)

Detailed description: This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized using an electronic randomization system to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2: 1:1. The investigator will be blinded to the patient's treatment group assignment and patients randomized to one of the 2 sponge groups will be blinded as to whether the sponge is active or placebo. If a patient has multiple infected ulcers, the assigned treatment will be administered to all infected ulcers. The investigator will determine the highest severity ulcer to be used for all efficacy evaluations and will also determine the size and number of sponges (up to 4) that a patient will use in order to completely cover all infected ulcers. The investigator will prescribe an empiric systemic antibiotic therapy based on protocol instructions. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. The investigator will stop study treatment if a patient achieves clinical cure by or after the 3rd treatment visit (approximately study day 15). After completing treatment, patients will return to the clinic for scheduled follow-up visits or until ulcer closure. The final efficacy assessments used in the primary efficacy analyses will be obtained at the first follow-up visit approximately 10 days after treatment is stopped. The remaining follow-up visits will occur at approximately 30, 60 and 90 days after treatment is stopped when patients will be assessed for ulcer closure and any re-infection.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.

- Has at least 1 skin ulcer located on or below the malleolus that presents with the

following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America guidelines for the "Diagnosis and Treatment of Diabetic Foot Infections" (CID 2012; 54: 132-173) (IDSA guidelines):

- has ≥ 2 manifestations of inflammation (local swelling or induration, erythema,

local tenderness or pain, local warmth, purulent discharge (thick, opaque to white or sanguineous secretion)

- has ≥ 1 of the following characteristics: erythema > 2cm, or involving

structures deeper than skin and subcutaneous tissues (e. g. abscess, osteomyelitis, septic arthritis, fasciitis) For patients with multiple infected ulcers, the ulcer with the highest Diabetic Foot Infection Wound score (DFI score) must be on or below the malleolus and all infected ulcers must be completely coverable using no more than 4 sponges (sponges cannot be cut).

- Has documented adequate arterial perfusion in the affected limb(s) (either palpable

dorsalis pedis and posterior tibial pulses, or normal Doppler wave forms, a toe blood pressure ≥ 45 mm Hg or participation is approved by a vascular surgeon)

- Has received appropriate surgical intervention to remove all necrotic and infected

bone if diagnosed with osteomyelitis.

- Has received appropriate surgical debridement to remove all gangrenous tissue.

Exclusion Criteria:

- Has a known history of hypersensitivity to gentamicin (or other aminoglycosides).

- Has a known or suspected hypersensitivity to bovine collagen.

- Has an ulcer infection which, based upon the patient's known history of

hypersensitivity and/or as otherwise in the opinion of the investigator, cannot be adequately treated with at least one of the empiric systemic antibiotic regimens allowed by this protocol.

- Has an ulcer associated with prosthetic material or an implanted device.

- Has received any systemic or topical antibiotic therapy for any reason within 7 days

of randomization unless it was administered to specifically treat the infected ulcer(s) and only within 36 hours of randomization.

- Requires or is likely to require treatment with any concomitant topical product or

wound therapy before the first follow-up study visit.

- Is severely immunocompromised, or likely to become severely immunocompromised during

the study, in the opinion of the investigator.

- Has a history of myasthenia gravis or other neurological condition where gentamicin

use is contraindicated as determined by the investigator.

- Has a history of epilepsy.

- Has a history of alcohol or substance abuse in the past 12 months.

- Has an uncontrolled illness that, in the opinion of the investigator, is likely to

cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study

Locations and Contacts

Lisa Hemsen, Phone: (860) 620-9201, Email: lhemsen@innocollinc.com

Anniston, Alabama 36207, United States; Recruiting

Fayetteville, Arkansas 72703, United States; Recruiting

Chino, California 91710, United States; Recruiting

Corona, California 92882, United States; Recruiting

Fresno, California 93720, United States; Recruiting

Fresno, California 93721, United States; Recruiting

Norwalk, Connecticut 06851, United States; Recruiting

Clermont, Florida 34711, United States; Recruiting

Cooper City, Florida 33024, United States; Recruiting

Coral Gables, Florida 33146, United States; Recruiting

Coral Gables, Florida 33134, United States; Recruiting

Hialeah, Florida 33012, United States; Recruiting

Hialeah, Florida 33016, United States; Recruiting

Miami Lakes, Florida 33016, United States; Recruiting

Miami Springs, Florida 33166, United States; Recruiting

Miami, Florida 33122, United States; Recruiting

Miami, Florida 33135, United States; Recruiting

Miami, Florida 33136, United States; Recruiting

Miami, Florida 33155, United States; Recruiting

Miami, Florida 33175, United States; Recruiting

Miami, Florida 33185, United States; Recruiting

New Port Ritchie, Florida 34653, United States; Recruiting

St. Petersburg, Florida 33713, United States; Recruiting

Weston, Florida 33326, United States; Recruiting

Columbus, Georgia 31904, United States; Recruiting

Marietta, Georgia 30060, United States; Recruiting

Avon, Indiana 46123, United States; Recruiting

Mooresville, Indiana 46158, United States; Recruiting

Muncie, Indiana 47304, United States; Recruiting

Phoenix, Maryland 21131, United States; Recruiting

Flint, Michigan 48504, United States; Recruiting

Las Vegas, Nevada 89101, United States; Recruiting

Las Vegas, Nevada 89109, United States; Recruiting

North Brunswick, New Jersey 08902, United States; Recruiting

Somerset, New Jersey 08873, United States; Recruiting

Hopewell Junction, New York 12533, United States; Recruiting

New Windsor, New York 12553, United States; Recruiting

Myrtle Beach, South Carolina 29572, United States; Recruiting

Houston, Texas 77024, United States; Recruiting

Lampasas, Texas 76550, United States; Recruiting

Lubbock, Texas 79410, United States; Recruiting

North Richland Hills, Texas 76180, United States; Recruiting

Sugar Land, Texas 77479, United States; Recruiting

Norfolk, Virginia 23507, United States; Recruiting

Wenatchee, Washington 98801, United States; Recruiting

Additional Information

Starting date: May 2015
Last updated: July 30, 2015

Page last updated: August 23, 2015

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