Status:
COMPLETED
Evaluation of a Medical Food for Chronic Wounds
Lead Sponsor:
Abbott Nutrition
Conditions:
Foot Ulcer, Diabetic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- non-pregnant
- diabetic
- neuropathic foot ulcer
- ABI\> 0.7
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT00711217
Start Date
June 1 2008
End Date
December 1 2010
Last Update
November 2 2011
Active Locations (51)
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1
University of Alabama
Birmingham, Alabama, United States, 35294-3360
2
Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
3
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
4
Foot and Ankle Specialist
Brawley, California, United States, 92227