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Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers (COACT-1)

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ClinicalTrials.gov Identifier: NCT02427802
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : August 25, 2021
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Innocoll

Tracking Information
First Submitted Date  ICMJE April 17, 2015
First Posted Date  ICMJE April 28, 2015
Results First Submitted Date  ICMJE May 28, 2021
Results First Posted Date  ICMJE August 25, 2021
Last Update Posted Date August 25, 2021
Study Start Date  ICMJE May 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2021)
  • Clinical Cure and Baseline Pathogen Eradication (Resolution of All Clinical Signs and Symptoms of Infection) and Baseline Pathogen Eradication) [ Time Frame: Approximately 10 days after end of treatment ]
    Percent of patients with both a clinical outcome of clinical cure (Resolution of all clinical signs and symptoms of infection) and baseline pathogen eradication at F/U visit 1
  • Reinfection (Percent of Patients With Re-infection) [ Time Frame: Approximately 90 days after end of treatment ]
    Percent of patients with re-infection
  • Time to Clinical Cure [ Time Frame: Approximately 10 days after end of treatment ]
    Actual time to clinical cure (Resolution of all clinical signs and symptoms of infection)
  • Amputation (Percent of Patients That Have an Amputation Associated With the Target Ulcer) [ Time Frame: Within approximately 90 days of end of treatment ]
    Percent of patients that have an amputation associated with the target ulcer
  • Ulcer Closure (Percent of Patients With Target Ulcer Closure) [ Time Frame: within approximately 30 days of end of treatment ]
    Percent of patients with ulcer closure within approximately 30 days of end of treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
  • Clinical cure and Baseline pathogen eradication (Resolution of all clinical signs and symptoms of infection) and baseline pathogen eradication) [ Time Frame: Approximately 10 days after end of treatment ]
    Percent of patients with both a clinical outcome of clinical cure (Resolution of all clinical signs and symptoms of infection) and baseline pathogen eradication at F/U visit 1
  • Reinfection (Percent of patients with re-infection) [ Time Frame: Approximately 90 days after end of treatment ]
    Percent of patients with re-infection
  • Time to Clinical Cure [ Time Frame: Approximately 10 days after end of treatment ]
    Actual time to clinical cure (Resolution of all clinical signs and symptoms of infection)
  • Amputation (Percent of patients that have an amputation associated with the target ulcer) [ Time Frame: Within approximately 90 days of end of treatment ]
    Percent of patients that have an amputation associated with the target ulcer
  • Ulcer closure (Percent of patients with target ulcer closure) [ Time Frame: within approximately 30 days of end of treatment ]
    Percent of patients with ulcer closure within approximately 30 days of end of treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Foot Ulcer, Diabetic
  • Infection
Intervention  ICMJE
  • 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
  • Other: Placebo
    Matching collagen sponge
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Gentamicin collagen sponge
  • 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.
    Intervention: Other: Placebo
  • No Intervention: No sponge group
    Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2021)
612
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2015)
500
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427802
Other Study ID Numbers  ICMJE INN-TOP-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innocoll
Study Sponsor  ICMJE Innocoll
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nigel Jones Vice President, Global Clinical Operations, Innocoll Pharmaceutical
PRS Account Innocoll
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP