Evaluation of a Medical Food for Chronic Wounds
Completed · Phase 3
Conditions studied: Foot Ulcer, Diabetic
In brief
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.
Key facts
- Study ID
- NCT00711217
- Run by
- Abbott Nutrition
- People needed
- 271
- Starts
- 2008-06-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2011-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- non-pregnant
- diabetic
- neuropathic foot ulcer
- ABI> 0.7
You may not qualify if…
- 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
Where it is running
- 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
- University of Alabama — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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