Evaluation of a Medical Food for Chronic Wounds

Foot Ulcer, Diabetic Clinical Trial

Official title:

Evaluation of a Medical Food for Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711217
• Other study ID #: BK15
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2008
• Last updated: November 1, 2011
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer, Diabetic

Intervention

Other:
• Medical Food
twice daily
• Drink mix calorically similar to experimental product
twice daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Countries where clinical trial is conducted

United States,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing		16 weeks	No
Secondary	QOL		16 weeks	No
Secondary	Wound healing measures		16 weeks	No
Secondary	Incidence of complications		16 weeks	No
Secondary	Clinical outcome data		16 weeks	No