COACT-2: Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
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 |
---|---|---|
|
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
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:
|
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
- 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
- Number of Patients With Re-infections [up to 90 days after treatment stopped]
- Time to Clinical Response [up to 90 days after treatment stopped]
Time in Days to Clinical Cure
- 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
-
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.- INN-TOP-005
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
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
|
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%
|
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
|
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
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 |
ctucker@innocoll.com |
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