Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers (COACT-2)
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|ClinicalTrials.gov Identifier: NCT02447172|
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : August 27, 2021
Last Update Posted : August 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer, Diabetic Infection||Drug: Gentamicin Collagen sponge Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||524 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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 Start Date :||June 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: 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.
Drug: 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)
Other Name: Cogenzia
Placebo Comparator: 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.
Matching placebo sponge
No Intervention: No sponge group
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
- Percent of Patients With a Clinical Outcome of Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection) [ Time Frame: approximately 10 days after end of treatment ]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
- Number of Patients With Re-infections [ Time Frame: up to 90 days after treatment stopped ]
- Time to Clinical Response [ Time Frame: up to 90 days after treatment stopped ]Time in Days to Clinical Cure
- Percent of Subjects That Had an Amputation Associated With the Target Ulcer [ Time Frame: up to 90 days after treatment stopped ]Modified Intent-to-Treat Population - Percent of subjects that had an amputation associated with the target ulcer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447172
|Study Director:||Nigel Jones||Vice President, Global Clinical Operations, Innocoll Pharmaceutical|