MedPath

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

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
NameTimeMethod
Wound healing16 weeks
Secondary Outcome Measures
NameTimeMethod
QOL16 weeks
Wound healing measures16 weeks
Incidence of complications16 weeks
Clinical outcome data16 weeks

Trial Locations

Locations (51)

University of Alabama

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

Southern Arizona VA Health Care System

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

Foot and Ankle Specialist

πŸ‡ΊπŸ‡Έ

Brawley, California, United States

Center for Clinical Research, Inc

πŸ‡ΊπŸ‡Έ

Castro Valley, California, United States

Central Coast Foot and Ankle

πŸ‡ΊπŸ‡Έ

Freedom, California, United States

Foot and Ankle Clinic

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

California School of Podiatric Medicine at Samuel Merritt University

πŸ‡ΊπŸ‡Έ

Oakland, California, United States

Therapeutics Clinical Research

πŸ‡ΊπŸ‡Έ

San Diego, California, United States

Advanced Clinical Research

πŸ‡ΊπŸ‡Έ

San Jose, California, United States

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University of Alabama
πŸ‡ΊπŸ‡ΈBirmingham, Alabama, United States

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