Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers

PHASE3TerminatedINTERVENTIONAL
Enrollment

396

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Diabetic Foot Ulcers
Interventions
DRUG

DSC127

DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever occurs sooner.

DRUG

placebo vehicle gel

DRUG

Standard of Care gel, Aquasite

Trial Locations (56)

1500

Worthwhile Clinical Trials, Benoni

1829

Dr Lakha's Consulting Rooms, Johannesburg

2113

Newtown Clincal Research Centre, Newtown

2157

Sunninghill Hospital, Sunninghill

4001

Synapta Clinical Research Centre, Durban

4068

Brookedale Clinical Research Centre, Phoenix

4091

Randles Road Medical Centre, Durban

4092

Flamco Clinical Trials, Durban

6020

GCT - Mercantile Clinical Trial Centre - Primecure Clinic, Port Elizabeth

6850

Boland Ethical Research Group, Worcester

7505

Tread Research, Parow

7530

Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town

9301

Iatros International, Bloemfontein

Josha Research, Bloemfontein

17403

Martin Foot & Ankle, York

19103

Paddington Testing Clinic, Philadelphia

24801

O'Malley Foot and Ankle, Wilmington

27533

Wayne Memorial Hospital, Goldsboro

32207

River City Clinical Research, Jacksonville

33013

Research in Miami, Inc., Hialeah

33136

Advanced Pharma CR, LLC, Miami

University of Miami, Miami

33140

New Phase Clincal Trials, Inc., Miami Beach

33165

Phoenix Medical Research, Miami

33308

Invesclinic, LLC, Fort Lauderdale

33472

Orthopedic Research Associates, Boynton Beach

42303

Bluegrass Foot Center c/o Research Concierge, LLC, Owensboro

45801

Regional Infectious Disease & Infusion Center Inc., Lima

48034

American Center for Clinical Trials, Southfield

71101

Grace Research, Shreveport

75231

North Texas Podiatric Medicine & Surgery, Dallas

76104

Bone and Joint Institute, Fort Worth

77074

Houston Foot & Ankle Specialists, Houston

80220

The Diabetic Foot and Wound Center, Denver

84119

Redwood Health Center, Salt Lake City

85008

Arizona Burn Center Maricopa Medical Center, Phoenix

85015

Associated Foot & Ankle Specialists, PC, Phoenix

85032

Ledesma Foot and Ankle, Phoenix

Precision Trials, Phoenix

85206

East Valley Foot and Ankle Specialist, Mesa

90063

Innovative Medical Technologies, LLC, Los Angeles

91316

Vladimir Zeetser, DPM, Encino

91710

Reliance Institute of Clinical Research, Chino

94115

Center for Clinical Research, Inc., San Francisco

94546

Center for Clinical Research, Inc., Castro Valley

94609

Samuel Merritt University, California School of Podiatric Medicine, Oakland

07630

Dr. Vincent Giacalone, Emerson

L8R 2R3

The Mayer Institute, Hamilton

N6C 5J1

Lawson Health Research Institute, London

L1N 2L1

Xceed Clinical, Whitby

J4B 5E4

Centre Podiatrique et Soins des Plaies, Boucherville

J1H 5N4

Centre de recherche du CHUS, Sherbrooke

00603

Centro de Curacion de Heridas del Caribe, Inc., Aguadilla

00795

Office of Renier D. Gonzalez-Cruz, MD, Juana Díaz

00909

Clinical Research Puerto Rico, San Juan

00918

Wound and Ulcer Care Clinic, San Juan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Integrium

INDUSTRY

lead

Integra LifeSciences Corporation

INDUSTRY

NCT01849965 - Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter