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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02447172
Ethics application status
Date submitted
14/05/2015
Date registered
18/05/2015
Date last updated
8/06/2016

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) - 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
Timepoint [1] 0 0
approximately 10 days after end of treatment
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Approximately 10 days after end of treatment
Secondary outcome [2] 0 0
Reinfection (Percent of patients with re-infection) - Percent of patients with re-infection
Timepoint [2] 0 0
Approximately 90 days after end of treatment
Secondary outcome [3] 0 0
Time to Clinical Cure - Actual time to clinical cure (Resolution of all clinical signs and symptoms of infection)
Timepoint [3] 0 0
Approximately 10 days after end of treatment
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Within approximately 90 days of end of treatment
Secondary outcome [5] 0 0
Ulcer closure (Percent of patients with target ulcer closure) - Percent of patients with ulcer closure within approximately 30 days of end of treatment
Timepoint [5] 0 0
within approximately 30 days of end of treatment

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
Gender
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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Czech Republic
State/province [10] 0 0
Brno
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Pardubice
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Praha 10
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Praha 2
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Praha 4
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Praha 6
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Trinec
Country [17] 0 0
Czech Republic
State/province [17] 0 0
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
Country [22] 0 0
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
Country [25] 0 0
Germany
State/province [25] 0 0
Sachsen
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Hungary
State/province [27] 0 0
Debrecen
Country [28] 0 0
Hungary
State/province [28] 0 0
Hatvan
Country [29] 0 0
Hungary
State/province [29] 0 0
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
Sátoraljaúhely
Country [33] 0 0
Ireland
State/province [33] 0 0
Waterford
Country [34] 0 0
Italy
State/province [34] 0 0
CB
Country [35] 0 0
Italy
State/province [35] 0 0
PD
Country [36] 0 0
Italy
State/province [36] 0 0
PT
Country [37] 0 0
Italy
State/province [37] 0 0
PV
Country [38] 0 0
Italy
State/province [38] 0 0
VI
Country [39] 0 0
Netherlands
State/province [39] 0 0
Almere
Country [40] 0 0
Netherlands
State/province [40] 0 0
Eindhoven
Country [41] 0 0
Netherlands
State/province [41] 0 0
Maastricht
Country [42] 0 0
Netherlands
State/province [42] 0 0
Nijmegen
Country [43] 0 0
Netherlands
State/province [43] 0 0
Nijmegn
Country [44] 0 0
Netherlands
State/province [44] 0 0
the Hague
Country [45] 0 0
Netherlands
State/province [45] 0 0
Utrecht
Country [46] 0 0
Poland
State/province [46] 0 0
Lower Silesia
Country [47] 0 0
Poland
State/province [47] 0 0
Chorzow
Country [48] 0 0
Poland
State/province [48] 0 0
Czestochowa
Country [49] 0 0
Poland
State/province [49] 0 0
Gdansk
Country [50] 0 0
Poland
State/province [50] 0 0
Krakow
Country [51] 0 0
Poland
State/province [51] 0 0
Lodz
Country [52] 0 0
Poland
State/province [52] 0 0
Lublin
Country [53] 0 0
Poland
State/province [53] 0 0
Poznan
Country [54] 0 0
Poland
State/province [54] 0 0
Studzionka
Country [55] 0 0
Poland
State/province [55] 0 0
Warszawa
Country [56] 0 0
Poland
State/province [56] 0 0
Zabrze
Country [57] 0 0
Slovakia
State/province [57] 0 0
Bratislava
Country [58] 0 0
Slovakia
State/province [58] 0 0
L'ubocna
Country [59] 0 0
Slovakia
State/province [59] 0 0
Nitra
Country [60] 0 0
Slovakia
State/province [60] 0 0
Trencín
Country [61] 0 0
Slovakia
State/province [61] 0 0
Trnava
Country [62] 0 0
Spain
State/province [62] 0 0
Barcelona
Country [63] 0 0
Spain
State/province [63] 0 0
Gipuzkoa
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Valencia
Country [66] 0 0
Spain
State/province [66] 0 0
Girona
Country [67] 0 0
Spain
State/province [67] 0 0
Lleida
Country [68] 0 0
Sweden
State/province [68] 0 0
Linköping
Country [69] 0 0
Sweden
State/province [69] 0 0
Lund
Country [70] 0 0
Sweden
State/province [70] 0 0
Stockholm
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Bradford
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Bristol
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Burton on Trent
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Coventry
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Derby
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Edinburgh
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Lancaster
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Liverpool
Country [79] 0 0
United Kingdom
State/province [79] 0 0
London
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Merthyr
Country [82] 0 0
United Kingdom
State/province [82] 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/show/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/show/NCT02447172