Evaluation of a Medical Food for Chronic Wounds

Phase 3

Completed

• Conditions: Foot Ulcer, Diabetic

• Registration Number: NCT00711217
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound healing	16 weeks

Secondary Outcome Measures

Name	Time	Method
QOL	16 weeks
Wound healing measures	16 weeks
Incidence of complications	16 weeks
Clinical outcome data	16 weeks

Trial Locations

Locations (51)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

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

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