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

NCT ID: NCT02447172

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 524 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-09-30

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.

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.

Conditions

Foot Ulcer, Diabetic; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gentamicin sponge group

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.

Group Type: EXPERIMENTAL

Gentamicin Collagen sponge

Intervention Type: DRUG

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

Placebo sponge group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo sponge

No sponge group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gentamicin Collagen sponge

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

Intervention Type: DRUG

Placebo

Matching placebo sponge

Intervention Type: OTHER

Other Intervention Names

Cogenzia

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innocoll

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nigel Jones

Role: STUDY_DIRECTOR

Vice President, Global Clinical Operations, Innocoll Pharmaceutical

Locations

Anniston, Alabama, United States

Las Vegas, Nevada, United States

Cowra, New South Wales, Australia

Spring Hill, Queensland, Australia

Graz, Styria, Austria

Vienna, , Austria

Vienna, , Austria

Brussels, , Belgium

Edegem, , Belgium

Kortrijk, , Belgium

Liége, , Belgium

Pellenberg, , Belgium

Brno, , Czechia

Pardubice, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Třinec, , Czechia

Zlín, , Czechia

Copenhagen, , Denmark

Hillerød, , Denmark

Bad Mergentheim, Baden-Wurttemberg, Germany

Aschaffenburg, Bavaria, Germany

Fulda, Hesse, Germany

Dortmund, North Rhine-Westphalia, Germany

Duisburg, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Bosenheim, Reinland-Pfalz, Germany

Dresden, Saxony, Germany

Pirna, Saxony, Germany

Berlin, , Germany

Debrecen, , Hungary

Hatvan, , Hungary

Orosháza, , Hungary

Sátoraljaújhely, , Hungary

Szekszárd, , Hungary

Székesfehérvár, , Hungary

Waterford, , Ireland

Campobasso, CB, Italy

Abano Terme, PD, Italy

Pistoia, Point, Italy

Pavia, PV, Italy

Bassano del Grappa, VI, Italy

Almere Stad, , Netherlands

Eindhoven, , Netherlands

Maastricht, , Netherlands

Nijmegen, , Netherlands

Nijmegen, , Netherlands

The Hague, , Netherlands

Utrecht, , Netherlands

Wroclaw, Lower Silesian Voivodeship, Poland

Chorzów, , Poland

Częstochowa, , Poland

Gdansk, , Poland

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Poznan, , Poland

Studzionka, , Poland

Warsaw, , Poland

Zabrze, , Poland

Bratislava, , Slovakia

Bratislava, , Slovakia

Ľubochňa, , Slovakia

Nitra, , Slovakia

Trenćín, , Slovakia

Trnava, , Slovakia

Badalona, Barcelona, Spain

Donostia / San Sebastian, Gipuzkoa, Spain

Alcorcón, Madrid, Spain

Manises, Valencia, Spain

Girona, , Spain

Lleida, , Spain

Madrid, , Spain

Madrid, , Spain

Linköping, , Sweden

Lund, , Sweden

Stockholm, , Sweden

Bradford, , United Kingdom

Bristol, , United Kingdom

Burton-on-Trent, , United Kingdom

Coventry, , United Kingdom

Derby, , United Kingdom

Edinburgh, , United Kingdom

Lancaster, , United Kingdom

Liverpool, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Merthyr, , United Kingdom

Stoke-on-Trent, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Czechia; Denmark; Germany; Hungary; Ireland; Italy; Netherlands; Poland; Slovakia; Spain; Sweden; United Kingdom

Other Identifiers

INN-TOP-005

Identifier Type: -

Identifier Source: org_study_id