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

NCT02427802 | Completed Phase 3 Results

• 1 other identifier: INN-TOP-004
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 86

Brief 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.

Conditions

Foot Ulcer, Diabetic; Infection

Outcome Measures

Primary Outcomes (1)

• Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection)

  The primary efficacy variable is the percent of patients with a clinical outcome of clinical cure (Resolution of all clinical signs and symptoms of infection) at F/U visit 1

  approximately 10 days after end of treatment

Secondary Outcomes (5)

• Clinical Cure and Baseline Pathogen Eradication (Resolution of All Clinical Signs and Symptoms of Infection) and Baseline Pathogen Eradication)

  Approximately 10 days after end of treatment

• Reinfection (Percent of Patients With Re-infection)

  Approximately 90 days after end of treatment

• Time to Clinical Cure

  Approximately 10 days after end of treatment

• Amputation (Percent of Patients That Have an Amputation Associated With the Target Ulcer)

  Within approximately 90 days of end of treatment

• Ulcer Closure (Percent of Patients With Target Ulcer Closure)

  within approximately 30 days of end of treatment

Study Arms (3)

Gentamicin sponge group

EXPERIMENTAL

Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.

Drug: Gentamicin collagen sponge

Placebo sponge group

PLACEBO COMPARATOR

Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.

Other: Placebo

No sponge group

NO INTERVENTION

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.

Interventions

Gentamicin collagen sponge DRUG

Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)

Also known as: Cogenzia

Gentamicin sponge group

Placebo OTHER

Matching collagen sponge

Placebo sponge group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Innocoll: lead

Study Sites (86)

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Anniston, Alabama, 36207, United States

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Mobile, Alabama, 36608, United States

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Mesa, Arizona, 85206, United States

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Phoenix, Arizona, 85032, United States

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Fayetteville, Arkansas, 72703, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Little Rock, Arkansas, 72212, United States

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Bakersfield, California, 93301, United States

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Chino, California, 91710, United States

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Corona, California, 92882, United States

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Fountain Valley, California, 36207, United States

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Fresno, California, 93720, United States

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Fresno, California, 93721, United States

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Fresno, California, 93722, United States

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Long Beach, California, 90822, United States

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Los Angeles, California, 90057, United States

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Oakland, California, 94609, United States

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San Francisco, California, 94115, United States

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Sylmar, California, 91342, United States

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Norwalk, Connecticut, 06851, United States

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Washington D.C., District of Columbia, 20007, United States

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Clermont, Florida, 34711, United States

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Cooper City, Florida, 33024, United States

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Coral Gables, Florida, 33134, United States

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Coral Gables, Florida, 33146, United States

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DeLand, Florida, 32720, United States

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Fleming Island, Florida, 32003, United States

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Hialeah, Florida, 33012, United States

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Hialeah, Florida, 33016, United States

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Hollywood, Florida, 33024, United States

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Miami, Florida, 33122, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33174, United States

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Miami, Florida, 33175, United States

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Miami, Florida, 33185, United States

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Miami Lakes, Florida, 33016, United States

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Miami Springs, Florida, 33166, United States

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New Port Richey, Florida, 34653, United States

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St. Petersburg, Florida, 33713, United States

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West Palm Beach, Florida, 33406, United States

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Weston, Florida, 33326, United States

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Augusta, Georgia, 30907, United States

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Columbus, Georgia, 31904, United States

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Marietta, Georgia, 30060, United States

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Idaho Falls, Idaho, 83404, United States

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Avon, Indiana, 46123, United States

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Mooresville, Indiana, 46158, United States

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Muncie, Indiana, 47304, United States

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Baltimore, Maryland, 21215, United States

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Phoenix, Maryland, 21131, United States

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Boston, Massachusetts, 02118, United States

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Flint, Michigan, 48504, United States

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Butte, Montana, 59701, United States

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Great Falls, Montana, 59405, United States

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Las Vegas, Nevada, 89101, United States

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North Brunswick, New Jersey, 08902, United States

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Somerset, New Jersey, 08873, United States

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Hopewell Junction, New York, 12533, United States

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New Windsor, New York, 12553, United States

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Durham, North Carolina, 27710, United States

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Lima, Ohio, 45801, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, 73139, United States

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Philadelphia, Pennsylvania, 19103, United States

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Philadelphia, Pennsylvania, 19106, United States

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Greenville, South Carolina, 29605, United States

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Myrtle Beach, South Carolina, 29572, United States

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West Columbia, South Carolina, 29169, United States

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Dallas, Texas, 75224, United States

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Houston, Texas, 77024, United States

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Lampasas, Texas, 76550, United States

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Lubbock, Texas, 79410, United States

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McAllen, Texas, 78501, United States

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North Richland Hills, Texas, 76180, United States

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San Antonio, Texas, 78209, United States

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San Antonio, Texas, 78224, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77479, United States

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Webster, Texas, 77598, United States

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Norfolk, Virginia, 23507, United States

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Virginia Beach, Virginia, 23464, United States

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Wenatchee, Washington, 98801, United States

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MeSH Terms

Conditions

Diabetic Foot; Infections

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Lesley Russell, MBChB, MRCP, Chief Medical Officer
• Organization: Innocoll

lrussell@innocoll.com

484-406-5206

Study Officials

• Nigel Jones

  Vice President, Global Clinical Operations, Innocoll Pharmaceutical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 28, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 25, 2021
• Results First Posted: August 25, 2021

Record last verified: 2021-08

Locations

US (86)