A Randomized, Double-Blind, Parallel-group, Vehicle and Standard of Care-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects With Diabetes Mellitus

Study Description

To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.

Study Details

Registry ID:

NCT01849965

Conditions:

Diabetic Foot Ulcers

Phase:

Phase 3

Target Enrollment:

396 participants

Start Date:

April 1, 2013

Age Range:

18–999 years

Healthy Volunteers:

No

Study Locations (56 sites)

• Sunninghill Hospital
  Sunninghill, GautengSouth Africa, South Africa
• Newtown Clincal Research Centre
  Newtown, GautengSouth Africa, South Africa
• Dr Lakha's Consulting Rooms
  Johannesburg, GautengSouth Africa, South Africa
• Worthwhile Clinical Trials
  Benoni, GautengSouth Africa, South Africa
• Tiervlei Trial Centre, Karl Bremer Hospital
  Cape Town, Western CapeSouth Africa, South Africa
• Tread Research
  Parow, Western CapeSouth Africa, South Africa
• Boland Ethical Research Group
  Worcester, Western CapeSouth Africa, South Africa
• Iatros International
  Bloemfontein, Free StateSouth Africa, South Africa
• Josha Research
  Bloemfontein, Free StateSouth Africa, South Africa
• GCT - Mercantile Clinical Trial Centre - Primecure Clinic
  Port Elizabeth, Eastern CapeSouth Africa, South Africa
• Brookedale Clinical Research Centre
  Phoenix, KwaZulu-NatalSouth Africa, South Africa
• Randles Road Medical Centre
  Durban, ZwaZulu NatalSouth Africa, South Africa
• Synapta Clinical Research Centre
  Durban, KwaZulu-NatalSouth Africa, South Africa
• Flamco Clinical Trials
  Durban, KwaZulu-NatalSouth Africa, South Africa
• Clinical Research Puerto Rico
  San JuanPuerto Rico, Puerto Rico
• Wound and Ulcer Care Clinic
  San JuanPuerto Rico, Puerto Rico
• Office of Renier D. Gonzalez-Cruz, MD
  Juana DíazPuerto Rico, Puerto Rico
• Centro de Curacion de Heridas del Caribe, Inc.
  AguadillaPuerto Rico, Puerto Rico
• New Phase Clincal Trials, Inc.
  Miami Beach, FloridaUnited States, United States
• Advanced Pharma CR, LLC
  Miami, FloridaUnited States, United States
• Phoenix Medical Research
  Miami, FloridaUnited States, United States
• University of Miami
  Miami, FloridaUnited States, United States
• Invesclinic, LLC
  Fort Lauderdale, FloridaUnited States, United States
• Research in Miami, Inc.
  Hialeah, FloridaUnited States, United States
• Orthopedic Research Associates
  Boynton Beach, FloridaUnited States, United States
• Dr. Vincent Giacalone
  Emerson, New JerseyUnited States, United States
• Centre de recherche du CHUS
  Sherbrooke, QuebecCanada, Canada
• Paddington Testing Clinic
  Philadelphia, PennsylvaniaUnited States, United States
• O'Malley Foot and Ankle
  Wilmington, North CarolinaUnited States, United States
• Wayne Memorial Hospital
  Goldsboro, North CarolinaUnited States, United States
• Centre Podiatrique et Soins des Plaies
  Boucherville, QuebecCanada, Canada
• Martin Foot & Ankle
  York, PennsylvaniaUnited States, United States
• River City Clinical Research
  Jacksonville, FloridaUnited States, United States
• Xceed Clinical
  Whitby, OntarioCanada, Canada
• The Mayer Institute
  Hamilton, OntarioCanada, Canada
• Lawson Health Research Institute
  London, OntarioCanada, Canada
• American Center for Clinical Trials
  Southfield, MichiganUnited States, United States
• Regional Infectious Disease & Infusion Center Inc.
  Lima, OhioUnited States, United States
• Bluegrass Foot Center c/o Research Concierge, LLC
  Owensboro, KentuckyUnited States, United States
• Grace Research
  Shreveport, LouisianaUnited States, United States
• Houston Foot & Ankle Specialists
  Houston, TexasUnited States, United States
• North Texas Podiatric Medicine & Surgery
  Dallas, TexasUnited States, United States
• Bone and Joint Institute
  Fort Worth, TexasUnited States, United States
• The Diabetic Foot and Wound Center
  Denver, ColoradoUnited States, United States
• East Valley Foot and Ankle Specialist
  Mesa, ArizonaUnited States, United States
• Precision Trials
  Phoenix, ArizonaUnited States, United States
• Ledesma Foot and Ankle
  Phoenix, ArizonaUnited States, United States
• Associated Foot & Ankle Specialists, PC
  Phoenix, ArizonaUnited States, United States
• Arizona Burn Center Maricopa Medical Center
  Phoenix, ArizonaUnited States, United States
• Redwood Health Center
  Salt Lake City, UtahUnited States, United States
• Reliance Institute of Clinical Research
  Chino, CaliforniaUnited States, United States
• Innovative Medical Technologies, LLC
  Los Angeles, CaliforniaUnited States, United States
• Vladimir Zeetser, DPM
  Encino, CaliforniaUnited States, United States
• Center for Clinical Research, Inc.
  Castro Valley, CaliforniaUnited States, United States
• Samuel Merritt University, California School of Podiatric Medicine
  Oakland, CaliforniaUnited States, United States
• Center for Clinical Research, Inc.
  San Francisco, CaliforniaUnited States, United States

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