Evaluation of a Medical Food for Chronic Wounds

November 1, 2011 updated by: Abbott Nutrition
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Clinica de Podologia, Ciudad Universitaria
      • Madrid, Spain, 28806
        • Centro de Diagnostico y Tratamiento Francisco Diaz
  • Taiwan
      • Taipei, Taiwan
        • Chang Gung memorial hospital
  • United Kingdom
      • London, United Kingdom
        • Diabetic Foot Clinic, King's College Hospital
      • Manchester, United Kingdom
        • Manchester Diabetes Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3360
        • University of Alabama
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System
      • Tucson, Arizona, United States, 85723
        • Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
    • California
      • Brawley, California, United States, 92227
        • Foot and Ankle Specialist
      • Castro Valley, California, United States, 94546
        • Center for Clinical Research, INC
      • Freedom, California, United States, 95019
        • Central Coast Foot and Ankle
      • Los Angeles, California, United States, 90010
        • Foot and Ankle Clinic
      • Oakland, California, United States, 94609
        • California School of Podiatric Medicine at Samuel Merritt University
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • San Jose, California, United States, 95116
        • Advanced Clinical Research
      • Stockton, California, United States, 95204
        • Pacific Wound Center
      • Torrance, California, United States, 90505
        • Precision Foot and Ankle Centers - Torrance
    • Colorado
      • Denver, Colorado, United States, 80220
        • Diabetic Foot and Wound Center
    • Connecticut
      • Watertown, Connecticut, United States, 06795
        • McHugh & Associates
    • Florida
      • Miami, Florida, United States, 33143
        • Doctor's Research Network
      • St. Petersburg, Florida, United States, 33710
        • SCORE Physician Alliance
      • Tamarac, Florida, United States, 33321
        • South Florida Wound Care Group
      • Temple Terrace, Florida, United States, 33617
        • Ankle and Foot Associates
    • Georgia
      • Evans, Georgia, United States, 30809
        • Aiyan Diabetes Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Garrett Noguchi, DPM, P.A.
    • Illinois
      • North Chicago, Illinois, United States, 60064
        • Rosalind Franklin University, Center for Lower Extremity Ambulatory Research
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Amputation Prevention Center Broadlawns Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Christus Schumpert Wound Care Center & Hyperbaric Center
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • Chesapeake Research Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Foot Care, Endovascular and Vascular Services Boston University School of Medicine
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center, Harvard University
    • Michigan
      • Southfield, Michigan, United States, 48034
        • American Center for Clinical Trials
      • Southfield, Michigan, United States, 48076
        • Foot Healthcare Associates
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Advance Foot & Ankle Center
      • Reno, Nevada, United States, 89502
        • VA Medical Center
    • New York
      • Port Jefferson Station, New York, United States, 11776
        • Gerard J. Furst, DPM, PLLC
    • Ohio
      • Akron, Ohio, United States, 44307
        • Akron General Medical Center, The Wound Care Center
      • Cleveland, Ohio, United States, 44115
        • St. Vincent Charity Hospital, Wound Care Center
      • Toledo, Ohio, United States, 43606
        • ProMedica Health Systems
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Blair Medical Associates, Inc.
      • Carlisle, Pennsylvania, United States, 17015
        • Carlisle Regional Medical Center, Advanced Wound Healing Center
      • Dunmore, Pennsylvania, United States, 18512
        • The Wound Institute and Research Center
      • Kittanning, Pennsylvania, United States, 16201
        • Armstrong County Wound Healing Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Temple University School of Podiatric Medicine
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Texas
      • Dallas, Texas, United States, 75231
        • Limb Salvage Centre
      • McAllen, Texas, United States, 78501
        • Complete Family Foot Care
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials, PA
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78212
        • Robert Wunderlich, DPM, P.A.
      • Tyler, Texas, United States, 75701
        • Trinity Mother Frances Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: #1 Medical food
Other: Medical Food
twice daily
Other Names:
  • AN0806A
Placebo Comparator: #2 Control
Other: Drink mix calorically similar to experimental product
twice daily
Other Names:
  • AN0806B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wound healing
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
QOL
Time Frame: 16 weeks
16 weeks
Wound healing measures
Time Frame: 16 weeks
16 weeks
Incidence of complications
Time Frame: 16 weeks
16 weeks
Clinical outcome data
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Director: Anne Voss, PhD, RD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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