NCT00711217
Completed
Phase 3
Evaluation of a Medical Food for Chronic Wounds
ConditionsFoot Ulcer, Diabetic
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Foot Ulcer, Diabetic
- Sponsor
- Abbott Nutrition
- Enrollment
- 271
- Locations
- 51
- Primary Endpoint
- Wound healing
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •non-pregnant
- •neuropathic foot ulcer
- •ABI\> 0.7
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Wound healing
Time Frame: 16 weeks
Secondary Outcomes
- QOL(16 weeks)
- Wound healing measures(16 weeks)
- Incidence of complications(16 weeks)
- Clinical outcome data(16 weeks)
Study Sites (51)
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