Clinical trial NCT00711217: Evaluation of a Medical Food for Chronic Wounds
Official title: Evaluation of a Medical Food for Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Foot Ulcer, Diabetic
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Wound healing
timeFrame: 16 weeks
Secondary outcomes:
measure: QOL
timeFrame: 16 weeks
measure: Wound healing measures
timeFrame: 16 weeks
measure: Incidence of complications
timeFrame: 16 weeks
measure: Clinical outcome data
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Tucson
country: United States
facility: Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Brawley
country: United States
facility: Foot and Ankle Specialist
state: California
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc
state: California
city: Freedom
country: United States
facility: Central Coast Foot and Ankle
state: California
city: Los Angeles
country: United States
facility: Foot and Ankle Clinic
state: California
city: Oakland
country: United States
facility: California School of Podiatric Medicine at Samuel Merritt University
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Jose
country: United States
facility: Advanced Clinical Research
state: California
city: Stockton
country: United States
facility: Pacific Wound Center
state: California
city: Torrance
country: United States
facility: Precision Foot and Ankle Centers - Torrance
state: California
city: Denver
country: United States
facility: Diabetic Foot and Wound Center
state: Colorado
city: Watertown
country: United States
facility: McHugh & Associates
state: Connecticut
city: Miami
country: United States
facility: Doctor's Research Network
state: Florida
city: St. Petersburg
country: United States
facility: SCORE Physician Alliance
state: Florida
city: Tamarac
country: United States
facility: South Florida Wound Care Group
state: Florida
city: Temple Terrace
country: United States
facility: Ankle and Foot Associates
state: Florida
city: Evans
country: United States
facility: Aiyan Diabetes Center
state: Georgia
city: Honolulu
country: United States
facility: Garrett Noguchi, DPM, P.A.
state: Hawaii
city: North Chicago
country: United States
facility: Rosalind Franklin University, Center for Lower Extremity Ambulatory Research
state: Illinois
city: Des Moines
country: United States
facility: Amputation Prevention Center Broadlawns Medical Center
state: Iowa
city: Shreveport
country: United States
facility: Christus Schumpert Wound Care Center & Hyperbaric Center
state: Louisiana
city: Pasadena
country: United States
facility: Chesapeake Research Group
state: Maryland
city: Boston
country: United States
facility: Foot Care, Endovascular and Vascular Services Boston University School of Medicine
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Harvard University
state: Massachusetts
city: Southfield
country: United States
facility: American Center for Clinical Trials
state: Michigan
city: Southfield
country: United States
facility: Foot Healthcare Associates
state: Michigan
city: Las Vegas
country: United States
facility: Advance Foot & Ankle Center
state: Nevada
city: Reno
country: United States
facility: VA Medical Center
state: Nevada
city: Port Jefferson Station
country: United States
facility: Gerard J. Furst, DPM, PLLC
state: New York
city: Akron
country: United States
facility: Akron General Medical Center, The Wound Care Center
state: Ohio
city: Cleveland
country: United States
facility: St. Vincent Charity Hospital, Wound Care Center
state: Ohio
city: Toledo
country: United States
facility: ProMedica Health Systems
state: Ohio
city: Altoona
country: United States
facility: Blair Medical Associates, Inc.
state: Pennsylvania
city: Carlisle
country: United States
facility: Carlisle Regional Medical Center, Advanced Wound Healing Center
state: Pennsylvania
city: Dunmore
country: United States
facility: The Wound Institute and Research Center
state: Pennsylvania
city: Kittanning
country: United States
facility: Armstrong County Wound Healing Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Podiatric Medicine
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Dallas
country: United States
facility: Limb Salvage Centre
state: Texas
city: McAllen
country: United States
facility: Complete Family Foot Care
state: Texas
city: San Antonio
country: United States
facility: Robert Wunderlich, DPM, P.A.
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Hospitals and Clinics
state: Texas
city: Madrid
country: Spain
facility: Clinica de Podologia, Ciudad Universitaria
city: Madrid
country: Spain
facility: Centro de Diagnostico y Tratamiento Francisco Diaz
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
city: London
country: United Kingdom
facility: Diabetic Foot Clinic, King's College Hospital
city: Manchester
country: United Kingdom
facility: Manchester Diabetes Centre
Study officials:
affiliation: Abbott Nutrition
name: Anne Voss, PhD, RD
role: STUDY_DIRECTOR
References: