COACT-2: Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

Sponsor
Innocoll (Industry)
Overall Status
Completed
CT.gov ID
NCT02447172
Collaborator
(none)
524
91
3
15
5.8
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gentamicin Collagen sponge
  • Other: Placebo
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
524 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • Cogenzia
  • 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.

    Other: Placebo
    Matching placebo sponge

    No Intervention: No sponge group

    Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.

    Outcome Measures

    Primary Outcome Measures

    1. Percent of Patients With a Clinical Outcome of Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection) [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

    Secondary Outcome Measures

    1. Number of Patients With Re-infections [up to 90 days after treatment stopped]

    2. Time to Clinical Response [up to 90 days after treatment stopped]

      Time in Days to Clinical Cure

    3. Percent of Subjects That Had an Amputation Associated With the Target Ulcer [up to 90 days after treatment stopped]

      Modified Intent-to-Treat Population - Percent of subjects that had an amputation associated with the target ulcer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anniston Alabama United States 36207
    2 Las Vegas Nevada United States 89109
    3 Cowra New South Wales Australia 2794
    4 Spring Hill Queensland Australia 4006
    5 Graz Styria Austria 8036
    6 Vienna Austria 1030
    7 Vienna Austria 1130
    8 Brussels Belgium 1090
    9 Edegem Belgium 2650
    10 Kortrijk Belgium 8500
    11 Liége Belgium 4000
    12 Pellenberg Belgium 3212
    13 Brno Czechia 656 91
    14 Pardubice Czechia 532 03
    15 Praha 10 Czechia 100 34
    16 Praha 2 Czechia 128 08
    17 Praha 4 Czechia 140 59
    18 Praha 6 Czechia 169 02
    19 Třinec Czechia 739 61
    20 Zlín Czechia 760 01
    21 Hillerød Denmark 3400
    22 København Denmark 2400
    23 Bad Mergentheim Baden-Württemberg Germany 97980
    24 Aschaffenburg Bayern Germany 63739
    25 Fulda Hessen Germany 36037
    26 Dortmund Nordrhein-Westfalen Germany 44137
    27 Duisburg Nordrhein-Westfalen Germany 47051
    28 Münster Nordrhein-Westfalen Germany 48145
    29 Bosenheim Reinland-Pfalz Germany 55545
    30 Dresden Sachsen Germany 01279
    31 Pirna Sachsen Germany 01796
    32 Berlin Germany 10787
    33 Debrecen Hungary 4032
    34 Hatvan Hungary 3000
    35 Orosháza Hungary 5900
    36 Szekszárd Hungary 7100
    37 Székesfehérvár Hungary 8000
    38 Sátoraljaújhely Hungary 3980
    39 Waterford Ireland
    40 Campobasso CB Italy 86100
    41 Abano Terme PD Italy 35031
    42 Pistoia Point Italy 51100
    43 Pavia PV Italy 27100
    44 Bassano del Grappa VI Italy 36061
    45 Almere Netherlands 1315RA
    46 Eindhoven Netherlands 5631BM
    47 Maastricht Netherlands 6229 HX
    48 Nijmegen Netherlands 6525 GA
    49 Nijmegen Netherlands 6532 SZ
    50 the Hague Netherlands 2526HW
    51 Utrecht Netherlands 3582KE
    52 Wrocław Lower Silesia Poland 51-124
    53 Chorzow Poland 41-400
    54 Czestochowa Poland 42-202
    55 Gdańsk Poland 80-952
    56 Krakow Poland 30-347
    57 Lodz Poland 90-553
    58 Lublin Poland 20-081
    59 Poznań Poland 616-111
    60 Studzionka Poland 43-245
    61 Warszawa Poland 02-541
    62 Zabrze Poland 41-819
    63 Bratislava Slovakia 81369
    64 Bratislava Slovakia 83103
    65 Nitra Slovakia 95001
    66 Trenćín Slovakia 91171
    67 Trnava Slovakia 917 75
    68 Ľubochňa Slovakia 034 91
    69 Badalona Barcelona Spain 08916
    70 San Sebastian Gipuzkoa Spain 20014
    71 Alcorcon Madrid Spain 23922
    72 Manises Valencia Spain 46940
    73 Girona Spain 17007
    74 Lleida Spain 25198
    75 Madrid Spain 28040
    76 Madrid Spain 46940
    77 Linköping Sweden 58185
    78 Lund Sweden 22185
    79 Stockholm Sweden 17176
    80 Bradford United Kingdom BD96RJ
    81 Bristol United Kingdom BS10 5NB
    82 Burton on Trent United Kingdom DE13 0RB
    83 Coventry United Kingdom CV22DX
    84 Derby United Kingdom DE22 3NE
    85 Edinburgh United Kingdom EH16 4SA
    86 Lancaster United Kingdom LA1 4RP
    87 Liverpool United Kingdom L7 8XP
    88 London United Kingdom NW3 2QG
    89 Manchester United Kingdom M23 9LT
    90 Merthyr United Kingdom CF47 9DT
    91 Stoke-on-Trent United Kingdom ST4 6QG

    Sponsors and Collaborators

    • Innocoll

    Investigators

    • Study Director: Nigel Jones, Vice President, Global Clinical Operations, Innocoll Pharmaceutical

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Innocoll
    ClinicalTrials.gov Identifier:
    NCT02447172
    Other Study ID Numbers:
    • INN-TOP-005
    First Posted:
    May 18, 2015
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Arm/Group Description 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. 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) Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching placebo sponge Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
    Period Title: Overall Study
    STARTED 262 130 132
    COMPLETED 231 115 114
    NOT COMPLETED 31 15 18

    Baseline Characteristics

    Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group Total
    Arm/Group Description 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. 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) Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching placebo sponge Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Total of all reporting groups
    Overall Participants 262 130 132 524
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.9
    (10.68)
    62.7
    (10.55)
    63.0
    (10.81)
    62.4
    (10.67)
    Sex: Female, Male (Count of Participants)
    Female
    63
    24%
    27
    20.8%
    28
    21.2%
    118
    22.5%
    Male
    199
    76%
    103
    79.2%
    104
    78.8%
    406
    77.5%
    Region of Enrollment (participants) [Number]
    Hungary
    28
    10.7%
    19
    14.6%
    15
    11.4%
    62
    11.8%
    United States
    6
    2.3%
    6
    4.6%
    3
    2.3%
    15
    2.9%
    United Kingdom
    10
    3.8%
    5
    3.8%
    5
    3.8%
    20
    3.8%
    Spain
    33
    12.6%
    10
    7.7%
    18
    13.6%
    61
    11.6%
    Czech Republic
    30
    11.5%
    17
    13.1%
    18
    13.6%
    65
    12.4%
    Austria
    2
    0.8%
    3
    2.3%
    0
    0%
    5
    1%
    Netherlands
    6
    2.3%
    0
    0%
    2
    1.5%
    8
    1.5%
    Sweden
    4
    1.5%
    1
    0.8%
    2
    1.5%
    7
    1.3%
    Belgium
    8
    3.1%
    4
    3.1%
    5
    3.8%
    17
    3.2%
    Poland
    70
    26.7%
    27
    20.8%
    35
    26.5%
    132
    25.2%
    Denmark
    2
    0.8%
    0
    0%
    0
    0%
    2
    0.4%
    Italy
    3
    1.1%
    3
    2.3%
    2
    1.5%
    8
    1.5%
    Slovakia
    18
    6.9%
    10
    7.7%
    13
    9.8%
    41
    7.8%
    Australia
    2
    0.8%
    3
    2.3%
    2
    1.5%
    7
    1.3%
    Germany
    21
    8%
    13
    10%
    9
    6.8%
    43
    8.2%
    Estonia
    3
    1.1%
    2
    1.5%
    5
    3.8%
    10
    1.9%
    Latvia
    12
    4.6%
    7
    5.4%
    1
    0.8%
    20
    3.8%
    Lithuania
    4
    1.5%
    0
    0%
    0
    0%
    4
    0.8%
    Ireland
    0
    0%
    0
    0%
    1
    0.8%
    1
    0.2%

    Outcome Measures

    1. Primary Outcome
    Title Percent of Patients With a Clinical Outcome of Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection)
    Description 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
    Time Frame approximately 10 days after end of treatment

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Arm/Group Description 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. 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) Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching placebo sponge Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
    Measure Participants 257 129 131
    Number [percentage of subjects]
    69
    41
    36
    2. Secondary Outcome
    Title Number of Patients With Re-infections
    Description
    Time Frame up to 90 days after treatment stopped

    Outcome Measure Data

    Analysis Population Description
    Modified Intent-to-Treat Population
    Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Arm/Group Description 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. 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) Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching placebo sponge Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
    Measure Participants 257 129 131
    Count of Participants [Participants]
    11
    4.2%
    2
    1.5%
    4
    3%
    3. Secondary Outcome
    Title Time to Clinical Response
    Description Time in Days to Clinical Cure
    Time Frame up to 90 days after treatment stopped

    Outcome Measure Data

    Analysis Population Description
    Modified Intent-to-Treat Population
    Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Arm/Group Description 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. 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) Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching placebo sponge Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
    Measure Participants 257 129 131
    Median (95% Confidence Interval) [Days]
    8
    8
    8
    4. Secondary Outcome
    Title Percent of Subjects That Had an Amputation Associated With the Target Ulcer
    Description Modified Intent-to-Treat Population - Percent of subjects that had an amputation associated with the target ulcer
    Time Frame up to 90 days after treatment stopped

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Arm/Group Description 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. 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) Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching placebo sponge Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
    Measure Participants 257 129 131
    Count of Participants [Participants]
    3
    1.1%
    0
    0%
    2
    1.5%

    Adverse Events

    Time Frame Approximately 28 days
    Adverse Event Reporting Description
    Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Arm/Group Description 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. 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) Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching placebo sponge Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
    All Cause Mortality
    Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/260 (1.2%) 1/129 (0.8%) 0/131 (0%)
    Serious Adverse Events
    Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 42/260 (16.2%) 26/129 (20.2%) 19/131 (14.5%)
    Blood and lymphatic system disorders
    anaemia 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    thrombocytosis 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Cardiac disorders
    acute myocardial infarction 2/260 (0.8%) 2 1/129 (0.8%) 1 0/131 (0%) 0
    cardiac failure 1/260 (0.4%) 1 2/129 (1.6%) 2 0/131 (0%) 0
    cardiac failure congestive 1/260 (0.4%) 1 1/129 (0.8%) 1 1/131 (0.8%) 1
    cardiac arrest 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    cardiac failure chronic 0/260 (0%) 0 0/129 (0%) 0 1/131 (0.8%) 1
    myocardial infarction 0/260 (0%) 0 0/129 (0%) 0 1/131 (0.8%) 1
    Gastrointestinal disorders
    gastrooesophageal reflux disease 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    General disorders
    generalixed oedema 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    impaired healing 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Infections and infestations
    infected skin ulcer 4/260 (1.5%) 4 4/129 (3.1%) 4 5/131 (3.8%) 5
    cellulitis 3/260 (1.2%) 3 4/129 (3.1%) 4 2/131 (1.5%) 2
    osteomyelitis 4/260 (1.5%) 4 3/129 (2.3%) 3 2/131 (1.5%) 2
    pneumonia 4/260 (1.5%) 4 1/129 (0.8%) 1 2/131 (1.5%) 2
    abscess limb 3/260 (1.2%) 3 0/129 (0%) 0 0/131 (0%) 0
    gangrene 1/260 (0.4%) 1 1/129 (0.8%) 1 0/131 (0%) 0
    sepsis 0/260 (0%) 0 1/129 (0.8%) 1 1/131 (0.8%) 1
    arthritis bacterial 0/260 (0%) 0 0/129 (0%) 0 1/131 (0.8%) 1
    diabetic gangrene 0/260 (0%) 0 0/129 (0%) 0 1/131 (0.8%) 1
    gastroenteritis 0/260 (0%) 0 0/129 (0%) 0 1/131 (0.8%) 1
    localised infection 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    lung infection 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    necrotising fasciitis 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    staphylococcal sepsis 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    superinfection 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Injury, poisoning and procedural complications
    vascular graft complication 0/260 (0%) 0 1/129 (0.8%) 1 0/131 (0%) 0
    vascular injury 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Investigations
    blood creatinine increased 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    c-reactive protein increased 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    creatinine renal clearance decreased 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    investigation 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Metabolism and nutrition disorders
    dehydration 2/260 (0.8%) 2 0/129 (0%) 0 0/131 (0%) 0
    hypoglycaemia 2/260 (0.8%) 2 0/129 (0%) 0 0/131 (0%) 0
    diabetic ketoacidosis 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    diabetic metabolic decompensation 0/260 (0%) 0 1/129 (0.8%) 1 0/131 (0%) 0
    hypercalcaemia 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    hyperglycaemia 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    hyperkalaemia 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    hyponatraemia 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    ketoacidosis 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Musculoskeletal and connective tissue disorders
    intervertebral disc disorder 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    neuropathic arthropathy 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    pancreatic carcinoma 0/260 (0%) 0 1/129 (0.8%) 1 0/131 (0%) 0
    Nervous system disorders
    ischaemic stroke 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    cerebral ischaemia 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Psychiatric disorders
    delirium tremens 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Renal and urinary disorders
    acute kidney injury 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    diabetic nephropathy 0/260 (0%) 0 1/129 (0.8%) 1 0/131 (0%) 0
    renal failure 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    asthma 0/260 (0%) 0 0/129 (0%) 0 1/131 (0.8%) 1
    chronic obstructive pulmonary disease 0/260 (0%) 0 1/129 (0.8%) 1 0/131 (0%) 0
    nocturnal dyspnoea 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    Skin and subcutaneous tissue disorders
    skin ulcer 3/260 (1.2%) 3 3/129 (2.3%) 3 1/131 (0.8%) 1
    diabetic foot 1/260 (0.4%) 1 0/129 (0%) 0 2/131 (1.5%) 2
    skin necrosis 1/260 (0.4%) 1 1/129 (0.8%) 1 0/131 (0%) 0
    Vascular disorders
    deep vein thrombosis 0/260 (0%) 0 3/129 (2.3%) 3 0/131 (0%) 0
    peripheral arterial occlusive disease 1/260 (0.4%) 1 0/129 (0%) 0 1/131 (0.8%) 1
    hypotension 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    peripheral ischaemia 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    poor peripheral circulation 0/260 (0%) 0 1/129 (0.8%) 1 0/131 (0%) 0
    shock haemorrhagic 1/260 (0.4%) 1 0/129 (0%) 0 0/131 (0%) 0
    vascular occlusion 0/260 (0%) 0 1/129 (0.8%) 1 0/131 (0%) 0
    Other (Not Including Serious) Adverse Events
    Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 48/260 (18.5%) 28/129 (21.7%) 20/131 (15.3%)
    Cardiac disorders
    Cardiac Failure 2/260 (0.8%) 2 3/129 (2.3%) 3 0/131 (0%) 0
    Ear and labyrinth disorders
    Vertigo 5/260 (1.9%) 5 3/129 (2.3%) 3 2/131 (1.5%) 2
    Gastrointestinal disorders
    diarrhoea 14/260 (5.4%) 14 4/129 (3.1%) 4 8/131 (6.1%) 8
    Nausea 9/260 (3.5%) 9 6/129 (4.7%) 6 4/131 (3.1%) 4
    General disorders
    Oedema Peripheral 2/260 (0.8%) 2 1/129 (0.8%) 1 4/131 (3.1%) 4
    Infections and infestations
    infected skin ulcer 36/260 (13.8%) 36 10/129 (7.8%) 10 16/131 (12.2%) 16
    Osteomyelitis 9/260 (3.5%) 9 4/129 (3.1%) 4 5/131 (3.8%) 5
    Urinary track Infection 4/260 (1.5%) 4 3/129 (2.3%) 3 6/131 (4.6%) 6
    Cellulitis 5/260 (1.9%) 5 4/129 (3.1%) 4 3/131 (2.3%) 3
    Abscess limb 7/260 (2.7%) 7 0/129 (0%) 0 2/131 (1.5%) 2
    Nasopharyngitis 4/260 (1.5%) 4 1/129 (0.8%) 1 3/131 (2.3%) 3
    Pneumonia 4/260 (1.5%) 4 1/129 (0.8%) 1 3/131 (2.3%) 3
    Respiratory, thoracic and mediastinal disorders
    Cough 1/260 (0.4%) 1 3/129 (2.3%) 3 4/131 (3.1%) 4
    Skin and subcutaneous tissue disorders
    skin ulcer 23/260 (8.8%) 23 16/129 (12.4%) 16 14/131 (10.7%) 14
    Diabetic Foot 2/260 (0.8%) 2 0/129 (0%) 0 3/131 (2.3%) 3
    Vascular disorders
    Hypertension 3/260 (1.2%) 3 3/129 (2.3%) 3 2/131 (1.5%) 2
    skin ulcer 23/260 (8.8%) 23 16/129 (12.4%) 16 14/131 (10.7%) 14
    Deep Vein Thrombosis 0/260 (0%) 0 3/129 (2.3%) 3 0/131 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    results of the multicenter study had to be published prior to the publication of any site specific data.

    Results Point of Contact

    Name/Title Charlene A. Tucker MS, Executive Director, Medical Writing and Document Management
    Organization Innocoll
    Phone 484-406-5211
    Email ctucker@innocoll.com
    Responsible Party:
    Innocoll
    ClinicalTrials.gov Identifier:
    NCT02447172
    Other Study ID Numbers:
    • INN-TOP-005
    First Posted:
    May 18, 2015
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021