Foot Ulcer, Diabetic
Conditions
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.
Interventions
OTHERMedical Food
twice daily
OTHERDrink mix calorically similar to experimental product
twice daily
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* non-pregnant * diabetic * 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 * myocardial infarction within 3 months * malnutrition * substance abuse * taking conflicting oral nutritional supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| QOL | 16 weeks |
| Wound healing measures | 16 weeks |
| Incidence of complications | 16 weeks |
| Clinical outcome data | 16 weeks |
Countries
Spain, Taiwan, United Kingdom, United States
Outcome results
None listed