Trial Outcomes & Findings for Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers (NCT NCT02447172)
NCT ID: NCT02447172
Last Updated: 2021-09-29
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
524 participants
Primary outcome timeframe
approximately 10 days after end of treatment
Results posted on
2021-09-29
Participant Flow
Participant milestones
| Measure |
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.
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)
|
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.
Placebo: Matching placebo sponge
|
No Sponge Group
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
262
|
130
|
132
|
|
Overall Study
COMPLETED
|
231
|
115
|
114
|
|
Overall Study
NOT COMPLETED
|
31
|
15
|
18
|
Reasons for withdrawal
| Measure |
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.
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)
|
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.
Placebo: Matching placebo sponge
|
No Sponge Group
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
8
|
7
|
|
Overall Study
Death
|
3
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
3
|
|
Overall Study
protocol specific treatment unrelated
|
3
|
0
|
2
|
Baseline Characteristics
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
Gentamicin Sponge Group
n=262 Participants
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)
|
Placebo Sponge Group
n=130 Participants
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
|
No Sponge Group
n=132 Participants
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
Total
n=524 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
199 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
406 Participants
n=483 Participants
|
|
Region of Enrollment
Hungary
|
28 participants
n=93 Participants
|
19 participants
n=4 Participants
|
15 participants
n=27 Participants
|
62 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
3 participants
n=27 Participants
|
15 participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
20 participants
n=483 Participants
|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 10.68 • n=93 Participants
|
62.7 years
STANDARD_DEVIATION 10.55 • n=4 Participants
|
63.0 years
STANDARD_DEVIATION 10.81 • n=27 Participants
|
62.4 years
STANDARD_DEVIATION 10.67 • n=483 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
118 Participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
33 participants
n=93 Participants
|
10 participants
n=4 Participants
|
18 participants
n=27 Participants
|
61 participants
n=483 Participants
|
|
Region of Enrollment
Czech Republic
|
30 participants
n=93 Participants
|
17 participants
n=4 Participants
|
18 participants
n=27 Participants
|
65 participants
n=483 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
0 participants
n=27 Participants
|
5 participants
n=483 Participants
|
|
Region of Enrollment
Netherlands
|
6 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
8 participants
n=483 Participants
|
|
Region of Enrollment
Sweden
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
7 participants
n=483 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
17 participants
n=483 Participants
|
|
Region of Enrollment
Poland
|
70 participants
n=93 Participants
|
27 participants
n=4 Participants
|
35 participants
n=27 Participants
|
132 participants
n=483 Participants
|
|
Region of Enrollment
Denmark
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
2 participants
n=483 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
2 participants
n=27 Participants
|
8 participants
n=483 Participants
|
|
Region of Enrollment
Slovakia
|
18 participants
n=93 Participants
|
10 participants
n=4 Participants
|
13 participants
n=27 Participants
|
41 participants
n=483 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
2 participants
n=27 Participants
|
7 participants
n=483 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=93 Participants
|
13 participants
n=4 Participants
|
9 participants
n=27 Participants
|
43 participants
n=483 Participants
|
|
Region of Enrollment
Estonia
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
5 participants
n=27 Participants
|
10 participants
n=483 Participants
|
|
Region of Enrollment
Latvia
|
12 participants
n=93 Participants
|
7 participants
n=4 Participants
|
1 participants
n=27 Participants
|
20 participants
n=483 Participants
|
|
Region of Enrollment
Lithuania
|
4 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
4 participants
n=483 Participants
|
|
Region of Enrollment
Ireland
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: approximately 10 days after end of treatmentPopulation: 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.
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
Outcome measures
| Measure |
Gentamicin Sponge Group
n=257 Participants
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)
|
Placebo Sponge Group
n=129 Participants
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
|
No Sponge Group
n=131 Participants
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
|---|---|---|---|
|
Percent of Patients With a Clinical Outcome of Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection)
|
69 percentage of subjects
|
41 percentage of subjects
|
36 percentage of subjects
|
SECONDARY outcome
Timeframe: up to 90 days after treatment stoppedPopulation: Modified Intent-to-Treat Population
Outcome measures
| Measure |
Gentamicin Sponge Group
n=257 Participants
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)
|
Placebo Sponge Group
n=129 Participants
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
|
No Sponge Group
n=131 Participants
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
|---|---|---|---|
|
Number of Patients With Re-infections
|
11 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 90 days after treatment stoppedPopulation: Modified Intent-to-Treat Population
Time in Days to Clinical Cure
Outcome measures
| Measure |
Gentamicin Sponge Group
n=257 Participants
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)
|
Placebo Sponge Group
n=129 Participants
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
|
No Sponge Group
n=131 Participants
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
|---|---|---|---|
|
Time to Clinical Response
|
8 Days
limits of the 95% Confidence Interval were not estimable due to insufficient number of events
|
8 Days
limits of the 95% Confidence Interval were not estimable due to insufficient number of events
|
8 Days
limits of the 95% Confidence Interval were not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: up to 90 days after treatment stoppedModified Intent-to-Treat Population - Percent of subjects that had an amputation associated with the target ulcer
Outcome measures
| Measure |
Gentamicin Sponge Group
n=257 Participants
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)
|
Placebo Sponge Group
n=129 Participants
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
|
No Sponge Group
n=131 Participants
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
|---|---|---|---|
|
Percent of Subjects That Had an Amputation Associated With the Target Ulcer
|
3 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Gentamicin Sponge Group
Serious events: 42 serious events
Other events: 48 other events
Deaths: 3 deaths
Placebo Sponge Group
Serious events: 26 serious events
Other events: 28 other events
Deaths: 1 deaths
No Sponge Group
Serious events: 19 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gentamicin Sponge Group
n=260 participants at risk
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)
|
Placebo Sponge Group
n=129 participants at risk
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
|
No Sponge Group
n=131 participants at risk
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
|---|---|---|---|
|
Infections and infestations
infected skin ulcer
|
1.5%
4/260 • Number of events 4 • Approximately 28 days
|
3.1%
4/129 • Number of events 4 • Approximately 28 days
|
3.8%
5/131 • Number of events 5 • Approximately 28 days
|
|
Infections and infestations
cellulitis
|
1.2%
3/260 • Number of events 3 • Approximately 28 days
|
3.1%
4/129 • Number of events 4 • Approximately 28 days
|
1.5%
2/131 • Number of events 2 • Approximately 28 days
|
|
Infections and infestations
osteomyelitis
|
1.5%
4/260 • Number of events 4 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
1.5%
2/131 • Number of events 2 • Approximately 28 days
|
|
Infections and infestations
pneumonia
|
1.5%
4/260 • Number of events 4 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
1.5%
2/131 • Number of events 2 • Approximately 28 days
|
|
Infections and infestations
abscess limb
|
1.2%
3/260 • Number of events 3 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Infections and infestations
gangrene
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Infections and infestations
sepsis
|
0.00%
0/260 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Infections and infestations
arthritis bacterial
|
0.00%
0/260 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Infections and infestations
diabetic gangrene
|
0.00%
0/260 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/260 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Infections and infestations
localised infection
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Infections and infestations
lung infection
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Infections and infestations
necrotising fasciitis
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Infections and infestations
staphylococcal sepsis
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Infections and infestations
superinfection
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Cardiac disorders
acute myocardial infarction
|
0.77%
2/260 • Number of events 2 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Cardiac disorders
cardiac failure
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
1.6%
2/129 • Number of events 2 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Cardiac disorders
cardiac failure congestive
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Cardiac disorders
cardiac arrest
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Cardiac disorders
cardiac failure chronic
|
0.00%
0/260 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/260 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
1.2%
3/260 • Number of events 3 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Skin and subcutaneous tissue disorders
diabetic foot
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
1.5%
2/131 • Number of events 2 • Approximately 28 days
|
|
Skin and subcutaneous tissue disorders
skin necrosis
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/260 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Vascular disorders
peripheral arterial occlusive disease
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Vascular disorders
hypotension
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Vascular disorders
peripheral ischaemia
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Vascular disorders
poor peripheral circulation
|
0.00%
0/260 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Vascular disorders
shock haemorrhagic
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Vascular disorders
vascular occlusion
|
0.00%
0/260 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
dehydration
|
0.77%
2/260 • Number of events 2 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.77%
2/260 • Number of events 2 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
diabetic ketoacidosis
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
diabetic metabolic decompensation
|
0.00%
0/260 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
hypercalcaemia
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
hyponatraemia
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Metabolism and nutrition disorders
ketoacidosis
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Investigations
blood creatinine increased
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Investigations
c-reactive protein increased
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Investigations
creatinine renal clearance decreased
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Investigations
investigation
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Nervous system disorders
ischaemic stroke
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Nervous system disorders
cerebral ischaemia
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Renal and urinary disorders
acute kidney injury
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Renal and urinary disorders
diabetic nephropathy
|
0.00%
0/260 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Renal and urinary disorders
renal failure
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.00%
0/260 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.76%
1/131 • Number of events 1 • Approximately 28 days
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/260 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Respiratory, thoracic and mediastinal disorders
nocturnal dyspnoea
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Blood and lymphatic system disorders
anaemia
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Blood and lymphatic system disorders
thrombocytosis
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
General disorders
generalixed oedema
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
General disorders
impaired healing
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Injury, poisoning and procedural complications
vascular graft complication
|
0.00%
0/260 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Injury, poisoning and procedural complications
vascular injury
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc disorder
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Musculoskeletal and connective tissue disorders
neuropathic arthropathy
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pancreatic carcinoma
|
0.00%
0/260 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Psychiatric disorders
delirium tremens
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
Other adverse events
| Measure |
Gentamicin Sponge Group
n=260 participants at risk
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)
|
Placebo Sponge Group
n=129 participants at risk
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
|
No Sponge Group
n=131 participants at risk
Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
|
|---|---|---|---|
|
Infections and infestations
infected skin ulcer
|
13.8%
36/260 • Number of events 36 • Approximately 28 days
|
7.8%
10/129 • Number of events 10 • Approximately 28 days
|
12.2%
16/131 • Number of events 16 • Approximately 28 days
|
|
Infections and infestations
Osteomyelitis
|
3.5%
9/260 • Number of events 9 • Approximately 28 days
|
3.1%
4/129 • Number of events 4 • Approximately 28 days
|
3.8%
5/131 • Number of events 5 • Approximately 28 days
|
|
Infections and infestations
Urinary track Infection
|
1.5%
4/260 • Number of events 4 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
4.6%
6/131 • Number of events 6 • Approximately 28 days
|
|
Infections and infestations
Cellulitis
|
1.9%
5/260 • Number of events 5 • Approximately 28 days
|
3.1%
4/129 • Number of events 4 • Approximately 28 days
|
2.3%
3/131 • Number of events 3 • Approximately 28 days
|
|
Infections and infestations
Abscess limb
|
2.7%
7/260 • Number of events 7 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
1.5%
2/131 • Number of events 2 • Approximately 28 days
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
4/260 • Number of events 4 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
2.3%
3/131 • Number of events 3 • Approximately 28 days
|
|
Infections and infestations
Pneumonia
|
1.5%
4/260 • Number of events 4 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
2.3%
3/131 • Number of events 3 • Approximately 28 days
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
8.8%
23/260 • Number of events 23 • Approximately 28 days
|
12.4%
16/129 • Number of events 16 • Approximately 28 days
|
10.7%
14/131 • Number of events 14 • Approximately 28 days
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.77%
2/260 • Number of events 2 • Approximately 28 days
|
0.00%
0/129 • Approximately 28 days
|
2.3%
3/131 • Number of events 3 • Approximately 28 days
|
|
Gastrointestinal disorders
diarrhoea
|
5.4%
14/260 • Number of events 14 • Approximately 28 days
|
3.1%
4/129 • Number of events 4 • Approximately 28 days
|
6.1%
8/131 • Number of events 8 • Approximately 28 days
|
|
Gastrointestinal disorders
Nausea
|
3.5%
9/260 • Number of events 9 • Approximately 28 days
|
4.7%
6/129 • Number of events 6 • Approximately 28 days
|
3.1%
4/131 • Number of events 4 • Approximately 28 days
|
|
Vascular disorders
Hypertension
|
1.2%
3/260 • Number of events 3 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
1.5%
2/131 • Number of events 2 • Approximately 28 days
|
|
Vascular disorders
skin ulcer
|
8.8%
23/260 • Number of events 23 • Approximately 28 days
|
12.4%
16/129 • Number of events 16 • Approximately 28 days
|
10.7%
14/131 • Number of events 14 • Approximately 28 days
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/260 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
General disorders
Oedema Peripheral
|
0.77%
2/260 • Number of events 2 • Approximately 28 days
|
0.78%
1/129 • Number of events 1 • Approximately 28 days
|
3.1%
4/131 • Number of events 4 • Approximately 28 days
|
|
Cardiac disorders
Cardiac Failure
|
0.77%
2/260 • Number of events 2 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
0.00%
0/131 • Approximately 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.38%
1/260 • Number of events 1 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
3.1%
4/131 • Number of events 4 • Approximately 28 days
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
5/260 • Number of events 5 • Approximately 28 days
|
2.3%
3/129 • Number of events 3 • Approximately 28 days
|
1.5%
2/131 • Number of events 2 • Approximately 28 days
|
Additional Information
Charlene A. Tucker MS, Executive Director, Medical Writing and Document Management
Innocoll
Phone: 484-406-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee results of the multicenter study had to be published prior to the publication of any site specific data.
- Publication restrictions are in place
Restriction type: OTHER