Evaluation of a Medical Food for Chronic Wounds

Abbott

Status and phase: Completed; Phase 3

Conditions: Foot Ulcer, Diabetic

Treatments: Other: Drink mix calorically similar to experimental product; Other: Medical Food

Study type: Interventional

Funder types: Industry

Identifiers

NCT00711217

BK15

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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271 participants in 2 patient groups, including a placebo group

#1 Medical food

Experimental group

Treatment:

Other: Medical Food

#2 Control

Placebo Comparator group

Treatment:

Other: Drink mix calorically similar to experimental product