Foot Ulcer, DiabeticPhase 3COACT-2NCT02447172

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 91 sites in 16 countries.

Completed

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

Official record

Search all trials

Trial summary

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: 524 participants
Where: 91 sitesin 16 countries
Study dates: Jun 2015to Sep 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

None listed.

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Has an uncontrolled illness that, in the opinion of the investigator, is likely to cause the patient to be withdrawn from the trial or would otherwise interfere with interpreting the results of the study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

91 sites in 16 countries.

Country

City, postcode or hospital

91 sites in 16 countries

United Kingdom12 sites

Study site
Bradford, BD96RJ
Study site
Bristol, BS10 5NB
Study site
Burton-on-Trent, DE13 0RB
Study site
Coventry, CV22DX
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Derby, DE22 3NE
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Edinburgh, EH16 4SA
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Lancaster, LA1 4RP
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Liverpool, L7 8XP
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London, NW3 2QG
Study site
Manchester, M23 9LT
Study site
Merthyr, CF47 9DT
Study site
Stoke-on-Trent, ST4 6QG

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Poland11 sites

Study site
Chorzów, 41-400
Study site
Częstochowa, 42-202
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Gdansk, 80-952
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Krakow, 30-347
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Lodz, 90-553
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Lublin, 20-081
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Poznan, 616-111
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Studzionka, 43-245
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Warsaw, 02-541
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Wroclaw, Lower Silesian Voivodeship, 51-124
Study site
Zabrze, 41-819

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Germany10 sites

Study site
Aschaffenburg, Bavaria, 63739
Study site
Bad Mergentheim, Baden-Wurttemberg, 97980
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Berlin, 10787
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Bosenheim, Reinland-Pfalz, 55545
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Dortmund, North Rhine-Westphalia, 44137
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Dresden, Saxony, 01279
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Duisburg, North Rhine-Westphalia, 47051
Study site
Fulda, Hesse, 36037
Study site
Münster, North Rhine-Westphalia, 48145
Study site
Pirna, Saxony, 01796

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Czechia8 sites

Study site
Brno, 656 91
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Pardubice, 532 03
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Prague, 100 34
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Prague, 128 08
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Prague, 140 59
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Prague, 169 02
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Třinec, 739 61
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Zlín, 760 01

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Spain8 sites

Study site
Alcorcón, Madrid, 23922
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Badalona, Barcelona, 08916
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Donostia / San Sebastian, Gipuzkoa, 20014
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Girona, 17007
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Lleida, 25198
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Madrid, 28040
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Madrid, 46940
Study site
Manises, Valencia, 46940

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Netherlands7 sites

Study site
Almere Stad, 1315RA
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Eindhoven, 5631BM
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Maastricht, 6229 HX
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Nijmegen, 6525 GA
Study site
Nijmegen, 6532 SZ
Study site
The Hague, 2526HW
Study site
Utrecht, 3582KE

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Hungary6 sites

Study site
Debrecen, 4032
Study site
Hatvan, 3000
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Orosháza, 5900
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Sátoraljaújhely, 3980
Study site
Székesfehérvár, 8000
Study site
Szekszárd, 7100

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Slovakia6 sites

Study site
Bratislava, 81369
Study site
Bratislava, 83103
Study site
Ľubochňa, 034 91
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Nitra, 95001
Study site
Trenćín, 91171
Study site
Trnava, 917 75

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Belgium5 sites

Study site
Brussels, 1090
Study site
Edegem, 2650
Study site
Kortrijk, 8500
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Liége, 4000
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Pellenberg, 3212

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Italy5 sites

Study site
Abano Terme, PD, 35031
Study site
Bassano del Grappa, VI, 36061
Study site
Campobasso, CB, 86100
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Pavia, PV, 27100
Study site
Pistoia, Point, 51100

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Austria3 sites

Study site
Graz, Styria, 8036
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Vienna, 1030
Study site
Vienna, 1130

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Sweden3 sites

Study site
Linköping, 58185
Study site
Lund, 22185
Study site
Stockholm, 17176

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United States2 sites

Study site
Anniston, Alabama, 36207
Study site
Las Vegas, Nevada, 89109

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Australia2 sites

Study site
Cowra, New South Wales, 2794
Study site
Spring Hill, Queensland, 4006

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Denmark2 sites

Study site
Copenhagen, 2400
Study site
Hillerød, 3400

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Ireland1 site

Study site
Waterford

Other trials in Ireland

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.

Conditions: Foot Ulcer, Diabetic, 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 placebo sponge

Study groups in NCT02447172
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Placebo
No sponge group	No intervention	Systemic 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.

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
Measured: approximately 10 days after end of treatment

Secondary outcomes (3)

Number of Patients With Re-infections
Measured: up to 90 days after treatment stopped
Time to Clinical Response
Time in Days to Clinical Cure
Measured: up to 90 days after treatment stopped
Percent of Subjects That Had an Amputation Associated With the Target Ulcer
Modified Intent-to-Treat Population - Percent of subjects that had an amputation associated with the target ulcer
Measured: up to 90 days after treatment stopped

Timeline

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

Jun 2015Sep 2016

First posted18 May 2015 (estimated)
Study startJun 2015
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 524 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02447172
Sponsor's protocol ID: INN-TOP-005
Acronym: COACT-2
Status last verified: Sep 2021
First submitted: 14 May 2015
Last updated: 29 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Foot Ulcer, Diabetic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02447172
Acronym / sponsor ID: COACT-2 / INN-TOP-005
Conditions: Foot Ulcer, Diabetic, Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 524 participants (actual)
Lead sponsor: InnocollIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 18 May 2015 (estimated)
Results: Posted 27 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Gentamicin sponge group	Experimental	Drug: Gentamicin Collagen spongeTopical 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.
Placebo sponge group	Placebo comparator	Other: PlaceboMatching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
No sponge group	No intervention	–Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gentamicin Collagen spongeAlso: CogenziaUp to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Drug	Gentamicin sponge group
PlaceboMatching placebo sponge	Other	Placebo sponge group

Primary outcome

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

3 secondary outcomes

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
Percent of Subjects That Had an Amputation Associated With the Target Ulcer
Time frame: up to 90 days after treatment stopped

Results and safety

Results posted to the registry on 27 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gentamicin Sponge Group	262	231
Placebo Sponge Group	130	115
No Sponge Group	132	114

Primary outcome: 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. Number. Unit: percentage of subjects

Measure	Gentamicin Sponge Group n = 257	Placebo Sponge Group n = 129	No Sponge Group n = 131
Value	69	41	36

Population analysed: modified intent to treat consisted of randomized patients who received any dose of gentamicin-sponge or placebo-sponge or who were randomized to the nosponge arm, and who were not early-terminated for one treatment-unrelated reasons before F/U visit 1.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 28 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gentamicin Sponge Group	42 of 260 (16.2%)	48 of 260 (18.5%)	3 of 260
Placebo Sponge Group	26 of 129 (20.2%)	28 of 129 (21.7%)	1 of 129
No Sponge Group	19 of 131 (14.5%)	20 of 131 (15.3%)	0 of 131

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Foot Ulcer, Diabetic

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nigel Jones study director

Vice President, Global Clinical Operations, Innocoll Pharmaceutical

91 sites in 16 countries: see every site and its status.

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 91 sites in 16 countries.

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 0 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 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United Kingdom, Poland, Germany, Czechia, Spain and 11 more countries. 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 27 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?

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). 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 NCT02447172.

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 29 Sep 2021.