Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
271 participants
INTERVENTIONAL
2008-06-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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#1 Medical food
Medical Food
twice daily
#2 Control
Drink mix calorically similar to experimental product
twice daily
Interventions
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Medical Food
twice daily
Drink mix calorically similar to experimental product
twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diabetic
* neuropathic foot ulcer
* ABI\> 0.7
Exclusion Criteria
* collagen vascular disease or autoimmune disease
* wound infection; recent therapies with steroids
* growth factor or bioengineered tissue
* radiation therapy
* treatment with antibiotics within 1 week, Charcot's arthropathy of the foot
* active malignancy
* renal function impairment
* liver failure
* planned surgery
* myocardial infarction within 3 months
* malnutrition
* substance abuse
* taking conflicting oral nutritional supplements
18 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Anne Voss, PhD, RD
Role: STUDY_DIRECTOR
Abbott Nutrition
Locations
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University of Alabama
Birmingham, Alabama, United States
Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
Tucson, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Foot and Ankle Specialist
Brawley, California, United States
Center for Clinical Research, Inc
Castro Valley, California, United States
Central Coast Foot and Ankle
Freedom, California, United States
Foot and Ankle Clinic
Los Angeles, California, United States
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Advanced Clinical Research
San Jose, California, United States
Pacific Wound Center
Stockton, California, United States
Precision Foot and Ankle Centers - Torrance
Torrance, California, United States
Diabetic Foot and Wound Center
Denver, Colorado, United States
McHugh & Associates
Watertown, Connecticut, United States
Doctor's Research Network
Miami, Florida, United States
SCORE Physician Alliance
St. Petersburg, Florida, United States
South Florida Wound Care Group
Tamarac, Florida, United States
Ankle and Foot Associates
Temple Terrace, Florida, United States
Aiyan Diabetes Center
Evans, Georgia, United States
Garrett Noguchi, DPM, P.A.
Honolulu, Hawaii, United States
Rosalind Franklin University, Center for Lower Extremity Ambulatory Research
North Chicago, Illinois, United States
Amputation Prevention Center Broadlawns Medical Center
Des Moines, Iowa, United States
Christus Schumpert Wound Care Center & Hyperbaric Center
Shreveport, Louisiana, United States
Chesapeake Research Group
Pasadena, Maryland, United States
Foot Care, Endovascular and Vascular Services Boston University School of Medicine
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Harvard University
Boston, Massachusetts, United States
American Center for Clinical Trials
Southfield, Michigan, United States
Foot Healthcare Associates
Southfield, Michigan, United States
Advance Foot & Ankle Center
Las Vegas, Nevada, United States
VA Medical Center
Reno, Nevada, United States
Gerard J. Furst, DPM, PLLC
Port Jefferson Station, New York, United States
Akron General Medical Center, The Wound Care Center
Akron, Ohio, United States
St. Vincent Charity Hospital, Wound Care Center
Cleveland, Ohio, United States
ProMedica Health Systems
Toledo, Ohio, United States
Blair Medical Associates, Inc.
Altoona, Pennsylvania, United States
Carlisle Regional Medical Center, Advanced Wound Healing Center
Carlisle, Pennsylvania, United States
The Wound Institute and Research Center
Dunmore, Pennsylvania, United States
Armstrong County Wound Healing Center
Kittanning, Pennsylvania, United States
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Limb Salvage Centre
Dallas, Texas, United States
Complete Family Foot Care
McAllen, Texas, United States
Robert Wunderlich, DPM, P.A.
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Trinity Mother Frances Hospitals and Clinics
Tyler, Texas, United States
Clinica de Podologia, Ciudad Universitaria
Madrid, , Spain
Centro de Diagnostico y Tratamiento Francisco Diaz
Madrid, , Spain
Chang Gung Memorial Hospital
Taipei, , Taiwan
Diabetic Foot Clinic, King's College Hospital
London, , United Kingdom
Manchester Diabetes Centre
Manchester, , United Kingdom
Countries
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Other Identifiers
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BK15
Identifier Type: -
Identifier Source: org_study_id