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Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers (COACT-1)

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ClinicalTrials.gov Identifier: NCT02427802
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : August 25, 2021
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Innocoll

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Foot Ulcer, Diabetic
Infection
Interventions Drug: Gentamicin collagen sponge
Other: Placebo
Enrollment 612
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Hide 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 collagen sponge

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Period Title: Overall Study
Started 305 154 153
Completed 246 120 110
Not Completed 59 34 43
Reason Not Completed
Adverse Event             11             3             7
Death             0             4             1
Lost to Follow-up             13             8             8
Physician Decision             4             2             4
Withdrawal by Subject             10             5             11
Protocol Violation             3             1             1
protocol specific treatment unrelated             18             11             11
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group Total
Hide 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 collagen sponge

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Total of all reporting groups
Overall Number of Baseline Participants 305 154 153 612
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 305 participants 154 participants 153 participants 612 participants
57.6  (10.84) 57.1  (11.12) 56.7  (11.16) 57.3  (10.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 305 participants 154 participants 153 participants 612 participants
Female
65
  21.3%
47
  30.5%
34
  22.2%
146
  23.9%
Male
240
  78.7%
107
  69.5%
119
  77.8%
466
  76.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 305 participants 154 participants 153 participants 612 participants
305 154 153 612
1.Primary Outcome
Title Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
modified intent to treat population consisted of randomized patients who received any dose of gentamicin-sponge or placebo-sponge or who were randomized to the no sponge arm, and who were not early-terminated for any of the treatment-unrelated reasons before F/U visit 1,
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Hide 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 collagen sponge

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Overall Number of Participants Analyzed 283 141 140
Measure Type: Count of Participants
Unit of Measure: Participants
115
  40.6%
64
  45.4%
48
  34.3%
2.Secondary Outcome
Title Clinical Cure and Baseline Pathogen Eradication (Resolution of All Clinical Signs and Symptoms of Infection) and Baseline Pathogen Eradication)
Hide Description 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
Time Frame Approximately 10 days after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Hide 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 collagen sponge

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Overall Number of Participants Analyzed 283 141 140
Measure Type: Count of Participants
Unit of Measure: Participants
87
  30.7%
47
  33.3%
34
  24.3%
3.Secondary Outcome
Title Reinfection (Percent of Patients With Re-infection)
Hide Description Percent of patients with re-infection
Time Frame Approximately 90 days after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Hide 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 collagen sponge

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Overall Number of Participants Analyzed 283 141 140
Measure Type: Count of Participants
Unit of Measure: Participants
12
   4.2%
5
   3.5%
2
   1.4%
4.Secondary Outcome
Title Time to Clinical Cure
Hide Description Actual time to clinical cure (Resolution of all clinical signs and symptoms of infection)
Time Frame Approximately 10 days after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Hide 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 collagen sponge

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Overall Number of Participants Analyzed 140 75 59
Median (95% Confidence Interval)
Unit of Measure: Days
41 [1] 
(30.0 to NA)
33 [1] 
(29.0 to NA)
46 [1] 
(30.0 to NA)
[1]
Upper boundary not reached
5.Secondary Outcome
Title Amputation (Percent of Patients That Have an Amputation Associated With the Target Ulcer)
Hide Description Percent of patients that have an amputation associated with the target ulcer
Time Frame Within approximately 90 days of end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Hide 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 collagen sponge

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Overall Number of Participants Analyzed 283 141 140
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.7%
3
   2.1%
5
   3.6%
6.Secondary Outcome
Title Ulcer Closure (Percent of Patients With Target Ulcer Closure)
Hide Description Percent of patients with ulcer closure within approximately 30 days of end of treatment
Time Frame within approximately 30 days of end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Hide 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 collagen sponge

Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Overall Number of Participants Analyzed 283 141 140
Measure Type: Count of Participants
Unit of Measure: Participants
67
  23.7%
32
  22.7%
29
  20.7%
Time Frame approximately 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Hide 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 collagen 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/305 (0.00%)      4/154 (2.60%)      1/153 (0.65%)    
Hide 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   44/305 (14.43%)      22/154 (14.29%)      26/153 (16.99%)    
Blood and lymphatic system disorders       
cardiac failure congestive  1  4/305 (1.31%)  4 1/154 (0.65%)  1 0/153 (0.00%)  0
anaemia  1  2/305 (0.66%)  2 0/154 (0.00%)  0 0/153 (0.00%)  0
Cardiac disorders       
cardiac arrest  1  0/305 (0.00%)  0 2/154 (1.30%)  2 0/153 (0.00%)  0
coronary artery disease  1  1/305 (0.33%)  1 1/154 (0.65%)  1 0/153 (0.00%)  0
acute myocardial infarction  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
angina pectoris  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
cardiac failure acute  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
mitral valve incompetence  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
myocardial infarction  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
pericardial effusion  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
ventricular tachycardia  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Gastrointestinal disorders       
diabetic gastroparesis  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
impaired gastric emptying  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
General disorders       
asthenia  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
chest pain  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
death  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
device extrusion  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
non-cardiac chest pain  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
hip fracture  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Hepatobiliary disorders       
cholecystitis acute  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
Infections and infestations       
osteomyelitis  1  7/305 (2.30%)  7 4/154 (2.60%)  4 7/153 (4.58%)  7
infected skin ulcer  1  7/305 (2.30%)  7 1/154 (0.65%)  1 4/153 (2.61%)  4
cellulitis  1  4/305 (1.31%)  4 1/154 (0.65%)  1 2/153 (1.31%)  2
osteomyelitis acute  1  3/305 (0.98%)  3 1/154 (0.65%)  1 2/153 (1.31%)  2
sepsis  1  3/305 (0.98%)  3 1/154 (0.65%)  1 0/153 (0.00%)  0
abscess limb  1  1/305 (0.33%)  1 0/154 (0.00%)  0 2/153 (1.31%)  2
gangrene  1  1/305 (0.33%)  1 1/154 (0.65%)  1 0/153 (0.00%)  0
influenza  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
localised infection  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
osteomyelitis chronic  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
post procedural infection  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
postoperative wound infection  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
streptococcal bacteraemia  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
Injury, poisoning and procedural complications       
head injury  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
limb injury  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
stab wound  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Metabolism and nutrition disorders       
decreased appetite  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
diabetes mellitus inadequate cotnrol  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
diabetic ketoacidosis  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
hypokalaemia  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
hyponatraemia  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
metabolic acidosis  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
type 2 diabetes mellitus  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Mueller's mixed tumour  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
Nervous system disorders       
syncope  1  2/305 (0.66%)  2 0/154 (0.00%)  0 0/153 (0.00%)  0
diabetic hyperosmolar coma  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
seizure  1  1/305 (0.33%)  1 0/154 (0.00%)  0 1/153 (0.65%)  1
transient ischaemic attack  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Psychiatric disorders       
mental status changes  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
suicidal ideation  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Renal and urinary disorders       
acute kidney injury  1  2/305 (0.66%)  2 1/154 (0.65%)  1 2/153 (1.31%)  2
chronic kidney disease  1  2/305 (0.66%)  2 0/154 (0.00%)  0 1/153 (0.65%)  1
haematuria  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Reproductive system and breast disorders       
penile necrosis  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
acute respiratory failure  1  1/305 (0.33%)  1 1/154 (0.65%)  1 0/153 (0.00%)  0
chronic obstructive pulmonary disease  1  0/305 (0.00%)  0 2/154 (1.30%)  2 0/153 (0.00%)  0
pulmonay embolism  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
pulmonary mass  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Skin and subcutaneous tissue disorders       
skin ulcer  1  3/305 (0.98%)  3 1/154 (0.65%)  1 0/153 (0.00%)  0
decubitus ulcer  1  1/305 (0.33%)  1 0/154 (0.00%)  0 0/153 (0.00%)  0
Vascular disorders       
hypotension  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
peripheral ischaemia  1  0/305 (0.00%)  0 1/154 (0.65%)  1 0/153 (0.00%)  0
peripheral vascular disorder  1  0/305 (0.00%)  0 0/154 (0.00%)  0 1/153 (0.65%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Gentamicin Sponge Group Placebo Sponge Group No Sponge Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   135/305 (44.26%)      72/154 (46.75%)      65/153 (42.48%)    
Ear and labyrinth disorders       
Vertigo  1  12/305 (3.93%)  12 4/154 (2.60%)  4 3/153 (1.96%)  3
Gastrointestinal disorders       
Nausea  1  22/305 (7.21%)  22 13/154 (8.44%)  13 6/153 (3.92%)  6
Diarrhoea  1  18/305 (5.90%)  18 3/154 (1.95%)  3 2/153 (1.31%)  2
Vomiting  1  7/305 (2.30%)  7 6/154 (3.90%)  6 2/153 (1.31%)  2
Constipation  1  2/305 (0.66%)  2 2/154 (1.30%)  2 3/153 (1.96%)  3
Immune system disorders       
Drug Hypersensitivity  1  3/305 (0.98%)  3 1/154 (0.65%)  1 3/153 (1.96%)  3
Infections and infestations       
infected skin ulcer  1  23/305 (7.54%)  23 11/154 (7.14%)  11 8/153 (5.23%)  8
Osteomyelitis  1  10/305 (3.28%)  10 8/154 (5.19%)  8 10/153 (6.54%)  10
Cellulitis  1  7/305 (2.30%)  7 4/154 (2.60%)  4 4/153 (2.61%)  4
Urinary Tract Infection  1  3/305 (0.98%)  3 4/154 (2.60%)  4 4/153 (2.61%)  4
Sepsis  1  6/305 (1.97%)  6 2/154 (1.30%)  2 0/153 (0.00%)  0
Upper Respiratory tract infection  1  3/305 (0.98%)  3 1/154 (0.65%)  1 3/153 (1.96%)  3
Injury, poisoning and procedural complications       
Fall  1  5/305 (1.64%)  5 7/154 (4.55%)  7 1/153 (0.65%)  1
Laceration  1  1/305 (0.33%)  1 3/154 (1.95%)  3 3/153 (1.96%)  3
Skin abrasion  1  2/305 (0.66%)  2 1/154 (0.65%)  1 4/153 (2.61%)  4
Metabolism and nutrition disorders       
Type 2 diabetes Mellitus  1  1/305 (0.33%)  1 1/154 (0.65%)  1 3/153 (1.96%)  3
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  4/305 (1.31%)  4 4/154 (2.60%)  4 0/153 (0.00%)  0
Renal and urinary disorders       
Acute Kidney Injury  1  8/305 (2.62%)  8 4/154 (2.60%)  4 3/153 (1.96%)  3
Skin and subcutaneous tissue disorders       
skin ulcer  1  26/305 (8.52%)  26 9/154 (5.84%)  9 11/153 (7.19%)  11
Blister  1  6/305 (1.97%)  6 2/154 (1.30%)  2 0/153 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results of the multicenter study had to be published prior to the publication of any site specific data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lesley Russell, MBChB, MRCP, Chief Medical Officer
Organization: Innocoll
Phone: 484-406-5206
EMail: lrussell@innocoll.com
Layout table for additonal information
Responsible Party: Innocoll
ClinicalTrials.gov Identifier: NCT02427802    
Other Study ID Numbers: INN-TOP-004
First Submitted: April 17, 2015
First Posted: April 28, 2015
Results First Submitted: May 28, 2021
Results First Posted: August 25, 2021
Last Update Posted: August 25, 2021