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

PHASE3CompletedINTERVENTIONAL
Enrollment

524

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
Foot Ulcer, DiabeticInfection
Interventions
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

Placebo

Matching placebo sponge

Trial Locations (91)

1030

Vienna

1090

Brussels

1130

Vienna

2400

Copenhagen

2650

Edegem

2794

Cowra

3000

Hatvan

3212

Pellenberg

3400

Hillerød

3980

Sátoraljaújhely

4000

Liége

4006

Spring Hill

4032

Debrecen

5900

Orosháza

7100

Szekszárd

8000

Székesfehérvár

8036

Graz

8500

Kortrijk

10787

Berlin

17007

Girona

17176

Stockholm

20014

Donostia / San Sebastian

22185

Lund

23922

Alcorcón

25198

Lleida

27100

Pavia

28040

Madrid

35031

Abano Terme

36037

Fulda

36061

Bassano del Grappa

36207

Anniston

44137

Dortmund

46940

Manises

Madrid

47051

Duisburg

48145

Münster

51100

Pistoia

55545

Bosenheim

58185

Linköping

63739

Aschaffenburg

81369

Bratislava

83103

Bratislava

86100

Campobasso

89109

Las Vegas

91171

Trenćín

95001

Nitra

97980

Bad Mergentheim

656 91

Brno

532 03

Pardubice

100 34

Prague

128 08

Prague

140 59

Prague

169 02

Prague

739 61

Třinec

760 01

Zlín

01279

Dresden

01796

Pirna

Unknown

Waterford

1315RA

Almere Stad

5631BM

Eindhoven

6229 HX

Maastricht

6525 GA

Nijmegen

6532 SZ

Nijmegen

2526HW

The Hague

3582KE

Utrecht

51-124

Wroclaw

41-400

Chorzów

42-202

Częstochowa

80-952

Gdansk

30-347

Krakow

90-553

Lodz

20-081

Lublin

616-111

Poznan

43-245

Studzionka

02-541

Warsaw

41-819

Zabrze

034 91

Ľubochňa

917 75

Trnava

08916

Badalona

BD96RJ

Bradford

BS10 5NB

Bristol

DE13 0RB

Burton-on-Trent

CV22DX

Coventry

DE22 3NE

Derby

EH16 4SA

Edinburgh

LA1 4RP

Lancaster

L7 8XP

Liverpool

NW3 2QG

London

M23 9LT

Manchester

CF47 9DT

Merthyr

ST4 6QG

Stoke-on-Trent

Sponsors

Lead Sponsor

All Listed Sponsors
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INDUSTRY