Evaluation of a Medical Food for Chronic Wounds
- Conditions
- Foot Ulcer, Diabetic
- 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
- 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)
University of Alabama
πΊπΈBirmingham, Alabama, United States
Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
πΊπΈTucson, Arizona, United States
Southern Arizona VA Health Care System
πΊπΈTucson, Arizona, United States
Foot and Ankle Specialist
πΊπΈBrawley, California, United States
Center for Clinical Research, Inc
πΊπΈCastro Valley, California, United States
Central Coast Foot and Ankle
πΊπΈFreedom, California, United States
Foot and Ankle Clinic
πΊπΈLos Angeles, California, United States
California School of Podiatric Medicine at Samuel Merritt University
πΊπΈOakland, California, United States
Therapeutics Clinical Research
πΊπΈSan Diego, California, United States
Advanced Clinical Research
πΊπΈSan Jose, California, United States
Scroll for more (41 remaining)University of AlabamaπΊπΈBirmingham, Alabama, United States