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Foot Ulcer, DiabeticPhase 3COACT-1NCT02427802

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

A Phase 3 study testing Gentamicin collagen sponge in people with Foot Ulcer, Diabetic and Infection, run by Innocoll at 86 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Foot Ulcer, Diabetic, Infection
What is being tested?
Gentamicin collagen sponge
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
612 participants
Where
86 sitesUnited States
Study dates
May 2015to Oct 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

United States86 sites

  • Study site

    Anniston, Alabama, 36207

  • Study site

    Augusta, Georgia, 30907

  • Study site

    Avon, Indiana, 46123

  • Study site

    Bakersfield, California, 93301

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Butte, Montana, 59701

  • Study site

    Chino, California, 91710

  • Study site

    Clermont, Florida, 34711

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Cooper City, Florida, 33024

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Coral Gables, Florida, 33146

  • Study site

    Corona, California, 92882

  • Study site

    Dallas, Texas, 75224

  • Study site

    DeLand, Florida, 32720

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Fayetteville, Arkansas, 72703

  • Study site

    Fleming Island, Florida, 32003

  • Study site

    Flint, Michigan, 48504

  • Study site

    Fountain Valley, California, 36207

  • Study site

    Fresno, California, 93720

  • Study site

    Fresno, California, 93721

  • Study site

    Fresno, California, 93722

  • Study site

    Great Falls, Montana, 59405

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Hollywood, Florida, 33024

  • Study site

    Hopewell Junction, New York, 12533

  • Study site

    Houston, Texas, 77024

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Lampasas, Texas, 76550

  • Study site

    Las Vegas, Nevada, 89101

  • Study site

    Lima, Ohio, 45801

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Little Rock, Arkansas, 72212

  • Study site

    Long Beach, California, 90822

  • Study site

    Los Angeles, California, 90057

  • Study site

    Lubbock, Texas, 79410

  • Study site

    Marietta, Georgia, 30060

  • Study site

    McAllen, Texas, 78501

  • Study site

    Mesa, Arizona, 85206

  • Study site

    Miami, Florida, 33122

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33155

  • Study site

    Miami, Florida, 33174

  • Study site

    Miami, Florida, 33175

  • Study site

    Miami, Florida, 33185

  • Study site

    Miami Lakes, Florida, 33016

  • Study site

    Miami Springs, Florida, 33166

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Mooresville, Indiana, 46158

  • Study site

    Muncie, Indiana, 47304

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    New Port Richey, Florida, 34653

  • Study site

    New Windsor, New York, 12553

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    North Brunswick, New Jersey, 08902

  • Study site

    North Richland Hills, Texas, 76180

  • Study site

    Norwalk, Connecticut, 06851

  • Study site

    Oakland, California, 94609

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Oklahoma City, Oklahoma, 73139

  • Study site

    Philadelphia, Pennsylvania, 19103

  • Study site

    Philadelphia, Pennsylvania, 19106

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Phoenix, Maryland, 21131

  • Study site

    San Antonio, Texas, 78209

  • Study site

    San Antonio, Texas, 78224

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Francisco, California, 94115

  • Study site

    Somerset, New Jersey, 08873

  • Study site

    St. Petersburg, Florida, 33713

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Sylmar, California, 91342

  • Study site

    Virginia Beach, Virginia, 23464

  • Study site

    Washington D.C., District of Columbia, 20007

  • Study site

    Webster, Texas, 77598

  • Study site

    Wenatchee, Washington, 98801

  • Study site

    West Columbia, South Carolina, 29169

  • Study site

    West Palm Beach, Florida, 33406

  • Study site

    Weston, Florida, 33326

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Gentamicin collagen sponge, Placebo
Medical subject headings
Diabetic Foot, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gentamicin collagen spongeDrug

    Also called Cogenzia

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

  • PlaceboOther

    Matching collagen sponge

Study groups in NCT02427802
Study groupRoleWhat they receive
Gentamicin sponge groupExperimentalTopical 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.
Receives: Drug: Gentamicin collagen sponge
Placebo sponge groupPlacebo comparatorMatching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Receives: Other: Placebo
No sponge groupNo interventionSystemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: approximately 10 days after end of treatment

Secondary outcomes (5)

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

    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

    Measured: Approximately 10 days after end of treatment

  2. Reinfection (Percent of Patients With Re-infection)

    Percent of patients with re-infection

    Measured: Approximately 90 days after end of treatment

  3. Time to Clinical Cure

    Actual time to clinical cure (Resolution of all clinical signs and symptoms of infection)

    Measured: Approximately 10 days after end of treatment

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

    Percent of patients that have an amputation associated with the target ulcer

    Measured: Within approximately 90 days of end of treatment

  5. Ulcer Closure (Percent of Patients With Target Ulcer Closure)

    Percent of patients with ulcer closure within approximately 30 days of end of treatment

    Measured: within approximately 30 days of end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
612 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02427802
Sponsor's protocol ID
INN-TOP-004
Acronym
COACT-1
Status last verified
Aug 2021
First submitted
17 Apr 2015
Last updated
25 Aug 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gentamicin collagen sponge in people with Foot Ulcer, Diabetic and Infection, run by Innocoll at 86 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection) (time frame: approximately 10 days after end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02427802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.

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