Evaluation of a Medical Food for Chronic Wounds
1 other identifier
interventional
271
4 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2008
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedNovember 2, 2011
May 1, 2011
2.5 years
June 23, 2008
November 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Wound healing
16 weeks
Secondary Outcomes (4)
QOL
16 weeks
Wound healing measures
16 weeks
Incidence of complications
16 weeks
Clinical outcome data
16 weeks
Study Arms (2)
#1 Medical food
EXPERIMENTAL#2 Control
PLACEBO COMPARATORInterventions
twice daily
Eligibility Criteria
You may qualify if:
- non-pregnant
- diabetic
- neuropathic foot ulcer
- ABI\> 0.7
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (51)
University of Alabama
Birmingham, Alabama, 35294-3360, United States
Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
Foot and Ankle Specialist
Brawley, California, 92227, United States
Center for Clinical Research, Inc
Castro Valley, California, 94546, United States
Central Coast Foot and Ankle
Freedom, California, 95019, United States
Foot and Ankle Clinic
Los Angeles, California, 90010, United States
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, 94609, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Advanced Clinical Research
San Jose, California, 95116, United States
Pacific Wound Center
Stockton, California, 95204, United States
Precision Foot and Ankle Centers - Torrance
Torrance, California, 90505, United States
Diabetic Foot and Wound Center
Denver, Colorado, 80220, United States
McHugh & Associates
Watertown, Connecticut, 06795, United States
Doctor's Research Network
Miami, Florida, 33143, United States
SCORE Physician Alliance
St. Petersburg, Florida, 33710, United States
South Florida Wound Care Group
Tamarac, Florida, 33321, United States
Ankle and Foot Associates
Temple Terrace, Florida, 33617, United States
Aiyan Diabetes Center
Evans, Georgia, 30809, United States
Garrett Noguchi, DPM, P.A.
Honolulu, Hawaii, 96817, United States
Rosalind Franklin University, Center for Lower Extremity Ambulatory Research
North Chicago, Illinois, 60064, United States
Amputation Prevention Center Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Christus Schumpert Wound Care Center & Hyperbaric Center
Shreveport, Louisiana, 71101, United States
Chesapeake Research Group
Pasadena, Maryland, 21122, United States
Foot Care, Endovascular and Vascular Services Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center, Harvard University
Boston, Massachusetts, 02215, United States
American Center for Clinical Trials
Southfield, Michigan, 48034, United States
Foot Healthcare Associates
Southfield, Michigan, 48076, United States
Advance Foot & Ankle Center
Las Vegas, Nevada, 89119, United States
VA Medical Center
Reno, Nevada, 89502, United States
Gerard J. Furst, DPM, PLLC
Port Jefferson Station, New York, 11776, United States
Akron General Medical Center, The Wound Care Center
Akron, Ohio, 44307, United States
St. Vincent Charity Hospital, Wound Care Center
Cleveland, Ohio, 44115, United States
ProMedica Health Systems
Toledo, Ohio, 43606, United States
Blair Medical Associates, Inc.
Altoona, Pennsylvania, 16602, United States
Carlisle Regional Medical Center, Advanced Wound Healing Center
Carlisle, Pennsylvania, 17015, United States
The Wound Institute and Research Center
Dunmore, Pennsylvania, 18512, United States
Armstrong County Wound Healing Center
Kittanning, Pennsylvania, 16201, United States
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Limb Salvage Centre
Dallas, Texas, 75231, United States
Complete Family Foot Care
McAllen, Texas, 78501, United States
Robert Wunderlich, DPM, P.A.
San Antonio, Texas, 78212, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229, United States
Trinity Mother Frances Hospitals and Clinics
Tyler, Texas, 75701, United States
Clinica de Podologia, Ciudad Universitaria
Madrid, 28040, Spain
Centro de Diagnostico y Tratamiento Francisco Diaz
Madrid, 28806, Spain
Chang Gung Memorial Hospital
Taipei, Taiwan
Diabetic Foot Clinic, King's College Hospital
London, United Kingdom
Manchester Diabetes Centre
Manchester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne Voss, PhD, RD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
July 8, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 2, 2011
Record last verified: 2011-05