Evaluation of a Medical Food for Chronic Wounds
- Conditions
- Foot Ulcer, Diabetic
- Interventions
- Other: Medical FoodOther: Drink mix calorically similar to experimental product
- Registration Number
- NCT00711217
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 271
- non-pregnant
- diabetic
- neuropathic foot ulcer
- ABI> 0.7
- uncontrolled DM
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description #1 Medical food Medical Food - #2 Control Drink mix calorically similar to experimental product -
- Primary Outcome Measures
Name Time Method Wound healing 16 weeks
- Secondary Outcome Measures
Name Time Method QOL 16 weeks Wound healing measures 16 weeks Incidence of complications 16 weeks Clinical outcome data 16 weeks
Trial Locations
- Locations (51)
Foot and Ankle Clinic
🇺🇸Los Angeles, California, United States
Beth Israel Deaconess Medical Center, Harvard University
🇺🇸Boston, Massachusetts, United States
American Center for Clinical Trials
🇺🇸Southfield, Michigan, United States
St. Vincent Charity Hospital, Wound Care Center
🇺🇸Cleveland, Ohio, United States
Carlisle Regional Medical Center, Advanced Wound Healing Center
🇺🇸Carlisle, Pennsylvania, United States
Limb Salvage Centre
🇺🇸Dallas, Texas, United States
Diabetic Foot Clinic, King's College Hospital
🇬🇧London, United Kingdom
Centro de Diagnostico y Tratamiento Francisco Diaz
🇪🇸Madrid, Spain
Trinity Mother Frances Hospitals and Clinics
🇺🇸Tyler, Texas, United States
Advance Foot & Ankle Center
🇺🇸Las Vegas, Nevada, 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
Diabetic Foot and Wound Center
🇺🇸Denver, Colorado, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Foot and Ankle Specialist
🇺🇸Brawley, California, United States
Central Coast Foot and Ankle
🇺🇸Freedom, California, United States
Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
Center for Clinical Research, Inc
🇺🇸Castro Valley, California, United States
Advanced Clinical Research
🇺🇸San Jose, California, United States
California School of Podiatric Medicine at Samuel Merritt University
🇺🇸Oakland, California, United States
McHugh & Associates
🇺🇸Watertown, Connecticut, United States
Pacific Wound Center
🇺🇸Stockton, California, United States
Doctor's Research Network
🇺🇸Miami, Florida, United States
SCORE Physician Alliance
🇺🇸St. Petersburg, Florida, United States
Aiyan Diabetes Center
🇺🇸Evans, Georgia, United States
Rosalind Franklin University, Center for Lower Extremity Ambulatory Research
🇺🇸North Chicago, Illinois, United States
South Florida Wound Care Group
🇺🇸Tamarac, Florida, United States
Ankle and Foot Associates
🇺🇸Temple Terrace, Florida, United States
Chesapeake Research Group
🇺🇸Pasadena, Maryland, United States
Christus Schumpert Wound Care Center & Hyperbaric Center
🇺🇸Shreveport, Louisiana, United States
Foot Care, Endovascular and Vascular Services Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
Gerard J. Furst, DPM, PLLC
🇺🇸Port Jefferson Station, New York, United States
Foot Healthcare Associates
🇺🇸Southfield, Michigan, United States
ProMedica Health Systems
🇺🇸Toledo, Ohio, United States
Armstrong County Wound Healing Center
🇺🇸Kittanning, Pennsylvania, United States
Temple University School of Podiatric Medicine
🇺🇸Philadelphia, Pennsylvania, United States
The Wound Institute and Research Center
🇺🇸Dunmore, Pennsylvania, United States
Blair Medical Associates, Inc.
🇺🇸Altoona, Pennsylvania, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Complete Family Foot Care
🇺🇸McAllen, Texas, United States
Clinica de Podologia, Ciudad Universitaria
🇪🇸Madrid, Spain
Chang Gung Memorial Hospital
🇨🇳Taipei, Taiwan
Manchester Diabetes Centre
🇬🇧Manchester, United Kingdom
Precision Foot and Ankle Centers - Torrance
🇺🇸Torrance, California, United States
Akron General Medical Center, The Wound Care Center
🇺🇸Akron, Ohio, United States
VA Medical Center
🇺🇸Reno, Nevada, United States
Garrett Noguchi, DPM, P.A.
🇺🇸Honolulu, Hawaii, United States
Amputation Prevention Center Broadlawns Medical Center
🇺🇸Des Moines, Iowa, United States