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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02447172




Registration number
NCT02447172
Ethics application status
Date submitted
14/05/2015
Date registered
18/05/2015
Date last updated
29/09/2021

Titles & IDs
Public title
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
Scientific 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
Secondary ID [1] 0 0
INN-TOP-005
Universal Trial Number (UTN)
Trial acronym
COACT-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot Ulcer, Diabetic 0 0
Infection 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gentamicin Collagen sponge
Other interventions - Placebo

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.

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.

No intervention: No sponge group - Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.


Treatment: Drugs: 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 interventions: Placebo
Matching placebo sponge
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Patients With a Clinical Outcome of Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection)
Timepoint [1] 0 0
approximately 10 days after end of treatment
Secondary outcome [1] 0 0
Number of Patients With Re-infections
Timepoint [1] 0 0
up to 90 days after treatment stopped
Secondary outcome [2] 0 0
Time to Clinical Response
Timepoint [2] 0 0
up to 90 days after treatment stopped
Secondary outcome [3] 0 0
Percent of Subjects That Had an Amputation Associated With the Target Ulcer
Timepoint [3] 0 0
up to 90 days after treatment stopped

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
524
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
- Cowra
Recruitment hospital [2] 0 0
- Spring Hill
Recruitment postcode(s) [1] 0 0
2794 - Cowra
Recruitment postcode(s) [2] 0 0
4006 - Spring Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Nevada
Country [3] 0 0
Austria
State/province [3] 0 0
Styria
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Edegem
Country [7] 0 0
Belgium
State/province [7] 0 0
Kortrijk
Country [8] 0 0
Belgium
State/province [8] 0 0
Liége
Country [9] 0 0
Belgium
State/province [9] 0 0
Pellenberg
Country [10] 0 0
Czechia
State/province [10] 0 0
Brno
Country [11] 0 0
Czechia
State/province [11] 0 0
Pardubice
Country [12] 0 0
Czechia
State/province [12] 0 0
Praha 10
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Czechia
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Praha 2
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Czechia
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Praha 4
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Czechia
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Praha 6
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Czechia
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Trinec
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Czechia
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Zlín
Country [18] 0 0
Denmark
State/province [18] 0 0
Hillerød
Country [19] 0 0
Denmark
State/province [19] 0 0
København
Country [20] 0 0
Germany
State/province [20] 0 0
Baden-Württemberg
Country [21] 0 0
Germany
State/province [21] 0 0
Bayern
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Germany
State/province [22] 0 0
Hessen
Country [23] 0 0
Germany
State/province [23] 0 0
Nordrhein-Westfalen
Country [24] 0 0
Germany
State/province [24] 0 0
Reinland-Pfalz
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Germany
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Sachsen
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Germany
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Berlin
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Hungary
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Debrecen
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Hungary
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Hatvan
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Hungary
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Orosháza
Country [30] 0 0
Hungary
State/province [30] 0 0
Szekszárd
Country [31] 0 0
Hungary
State/province [31] 0 0
Székesfehérvár
Country [32] 0 0
Hungary
State/province [32] 0 0
Sátoraljaújhely
Country [33] 0 0
Ireland
State/province [33] 0 0
Waterford
Country [34] 0 0
Italy
State/province [34] 0 0
CB
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Italy
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PD
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Italy
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Point
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Italy
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PV
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Italy
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VI
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Netherlands
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Almere
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Netherlands
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Eindhoven
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Netherlands
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Maastricht
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Netherlands
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Nijmegen
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Netherlands
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the Hague
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Netherlands
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Utrecht
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Poland
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Lower Silesia
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Poland
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Chorzow
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Czestochowa
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Gdansk
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Poland
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Krakow
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Lodz
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Lublin
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Poland
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Poznan
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Poland
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Studzionka
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Poland
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Warszawa
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Poland
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Zabrze
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Slovakia
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Bratislava
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Slovakia
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Nitra
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Slovakia
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Trencín
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Slovakia
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Trnava
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Slovakia
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Lubochna
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Spain
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Barcelona
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Spain
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Gipuzkoa
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Spain
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Madrid
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Spain
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Valencia
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Spain
State/province [65] 0 0
Girona
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Spain
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Lleida
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Sweden
State/province [67] 0 0
Linköping
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Sweden
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Lund
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Sweden
State/province [69] 0 0
Stockholm
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Bradford
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United Kingdom
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Bristol
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United Kingdom
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Burton on Trent
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United Kingdom
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Coventry
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United Kingdom
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Derby
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United Kingdom
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Edinburgh
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United Kingdom
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Lancaster
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Merthyr
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Innocoll
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02447172
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nigel Jones
Address 0 0
Vice President, Global Clinical Operations, Innocoll Pharmaceutical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02447172