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

NCT02447172 | Completed Phase 3 Results

• 1 other identifier: INN-TOP-005
• Study Type: interventional
• Target: 524
• Locations: 15 countries
• Sites: 89

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)

• Percent of Patients With a Clinical Outcome of 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 (3)

• Number of Patients With Re-infections

  up to 90 days after treatment stopped

• Time to Clinical Response

  up to 90 days after treatment stopped

• Percent of Subjects That Had an Amputation Associated With the Target Ulcer

  up to 90 days after treatment stopped

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 placebo 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 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 (91)

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Anniston, Alabama, 36207, United States

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Las Vegas, Nevada, 89109, United States

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Cowra, New South Wales, 2794, Australia

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Spring Hill, Queensland, 4006, Australia

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Graz, Styria, 8036, Austria

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Vienna, 1030, Austria

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Vienna, 1130, Austria

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Brussels, 1090, Belgium

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Edegem, 2650, Belgium

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Kortrijk, 8500, Belgium

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Liége, 4000, Belgium

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Pellenberg, 3212, Belgium

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Brno, 656 91, Czechia

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Pardubice, 532 03, Czechia

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Prague, 100 34, Czechia

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Prague, 128 08, Czechia

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Prague, 140 59, Czechia

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Prague, 169 02, Czechia

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Třinec, 739 61, Czechia

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Zlín, 760 01, Czechia

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Copenhagen, 2400, Denmark

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Hillerød, 3400, Denmark

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Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

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Aschaffenburg, Bavaria, 63739, Germany

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Fulda, Hesse, 36037, Germany

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Dortmund, North Rhine-Westphalia, 44137, Germany

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Duisburg, North Rhine-Westphalia, 47051, Germany

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Münster, North Rhine-Westphalia, 48145, Germany

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Bosenheim, Reinland-Pfalz, 55545, Germany

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Dresden, Saxony, 01279, Germany

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Pirna, Saxony, 01796, Germany

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Berlin, 10787, Germany

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Debrecen, 4032, Hungary

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Hatvan, 3000, Hungary

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Orosháza, 5900, Hungary

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Sátoraljaújhely, 3980, Hungary

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Szekszárd, 7100, Hungary

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Székesfehérvár, 8000, Hungary

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Waterford, Ireland

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Campobasso, CB, 86100, Italy

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Abano Terme, PD, 35031, Italy

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Pistoia, Point, 51100, Italy

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Pavia, PV, 27100, Italy

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Bassano del Grappa, VI, 36061, Italy

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Almere Stad, 1315RA, Netherlands

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Eindhoven, 5631BM, Netherlands

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Maastricht, 6229 HX, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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The Hague, 2526HW, Netherlands

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Utrecht, 3582KE, Netherlands

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Wroclaw, Lower Silesian Voivodeship, 51-124, Poland

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Chorzów, 41-400, Poland

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Częstochowa, 42-202, Poland

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Gdansk, 80-952, Poland

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Krakow, 30-347, Poland

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Lodz, 90-553, Poland

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Lublin, 20-081, Poland

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Poznan, 616-111, Poland

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Studzionka, 43-245, Poland

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Warsaw, 02-541, Poland

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Zabrze, 41-819, Poland

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Bratislava, 81369, Slovakia

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Bratislava, 83103, Slovakia

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Ľubochňa, 034 91, Slovakia

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Nitra, 95001, Slovakia

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Trenćín, 91171, Slovakia

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Trnava, 917 75, Slovakia

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Badalona, Barcelona, 08916, Spain

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Donostia / San Sebastian, Gipuzkoa, 20014, Spain

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Alcorcón, Madrid, 23922, Spain

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Manises, Valencia, 46940, Spain

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Girona, 17007, Spain

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Lleida, 25198, Spain

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Madrid, 28040, Spain

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Madrid, 46940, Spain

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Linköping, 58185, Sweden

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Lund, 22185, Sweden

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Stockholm, 17176, Sweden

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Bradford, BD96RJ, United Kingdom

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Bristol, BS10 5NB, United Kingdom

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Burton-on-Trent, DE13 0RB, United Kingdom

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Coventry, CV22DX, United Kingdom

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Derby, DE22 3NE, United Kingdom

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Edinburgh, EH16 4SA, United Kingdom

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Lancaster, LA1 4RP, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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London, NW3 2QG, United Kingdom

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Manchester, M23 9LT, United Kingdom

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Merthyr, CF47 9DT, United Kingdom

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Stoke-on-Trent, ST4 6QG, United Kingdom

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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: Charlene A. Tucker MS, Executive Director, Medical Writing and Document Management
• Organization: Innocoll

ctucker@innocoll.com

484-406-5211

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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 18, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 29, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-09

Locations

AU (3); DE (10); IE (1); PL (11); GB (12); BE (5); US (2); HU (6); SL (6); ES (8); CZ (8); SE (3); NL (7); DK (2); IT (5)