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

PHASE3CompletedINTERVENTIONAL
Enrollment

612

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 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 collagen sponge

Trial Locations (86)

12533

Hopewell Junction

12553

New Windsor

19103

Philadelphia

19106

Philadelphia

20007

Washington D.C.

21131

Phoenix

21215

Baltimore

23464

Virginia Beach

23507

Norfolk

27710

Durham

29169

West Columbia

29572

Myrtle Beach

29605

Greenville

30060

Marietta

30907

Augusta

31904

Columbus

32003

Fleming Island

32720

DeLand

33012

Hialeah

33016

Hialeah

Miami Lakes

33024

Cooper City

Hollywood

33122

Miami

33126

Miami

33134

Coral Gables

33135

Miami

33136

Miami

33146

Coral Gables

33155

Miami

33166

Miami Springs

33174

Miami

33175

Miami

33185

Miami

33326

Weston

33406

West Palm Beach

33713

St. Petersburg

34653

New Port Richey

34711

Clermont

36207

Anniston

Fountain Valley

36608

Mobile

45801

Lima

46123

Avon

46158

Mooresville

47304

Muncie

48504

Flint

59405

Great Falls

59701

Butte

72205

Little Rock

72212

Little Rock

72401

Jonesboro

72703

Fayetteville

73104

Oklahoma City

73139

Oklahoma City

75224

Dallas

76180

North Richland Hills

76550

Lampasas

77024

Houston

77479

Sugar Land

77598

Webster

78209

San Antonio

78224

San Antonio

78229

San Antonio

78501

McAllen

79410

Lubbock

83404

Idaho Falls

85032

Phoenix

85206

Mesa

89101

Las Vegas

90057

Los Angeles

90822

Long Beach

91342

Sylmar

91710

Chino

92882

Corona

93301

Bakersfield

93720

Fresno

93721

Fresno

93722

Fresno

94115

San Francisco

94609

Oakland

98801

Wenatchee

06851

Norwalk

02118

Boston

08902

North Brunswick

08873

Somerset

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