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Evaluation of a Medical Food for Chronic Wounds

Primary Purpose

Foot Ulcer, Diabetic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Medical Food
Drink mix calorically similar to experimental product
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
  • Southern Arizona VA Health Care System
  • Foot and Ankle Specialist
  • Center for Clinical Research, Inc
  • Central Coast Foot and Ankle
  • Foot and Ankle Clinic
  • California School of Podiatric Medicine at Samuel Merritt University
  • Therapeutics Clinical Research
  • Advanced Clinical Research
  • Pacific Wound Center
  • Precision Foot and Ankle Centers - Torrance
  • Diabetic Foot and Wound Center
  • McHugh & Associates
  • Doctor's Research Network
  • SCORE Physician Alliance
  • South Florida Wound Care Group
  • Ankle and Foot Associates
  • Aiyan Diabetes Center
  • Garrett Noguchi, DPM, P.A.
  • Rosalind Franklin University, Center for Lower Extremity Ambulatory Research
  • Amputation Prevention Center Broadlawns Medical Center
  • Christus Schumpert Wound Care Center & Hyperbaric Center
  • Chesapeake Research Group
  • Foot Care, Endovascular and Vascular Services Boston University School of Medicine
  • Beth Israel Deaconess Medical Center, Harvard University
  • American Center for Clinical Trials
  • Foot Healthcare Associates
  • Advance Foot & Ankle Center
  • VA Medical Center
  • Gerard J. Furst, DPM, PLLC
  • Akron General Medical Center, The Wound Care Center
  • St. Vincent Charity Hospital, Wound Care Center
  • ProMedica Health Systems
  • Blair Medical Associates, Inc.
  • Carlisle Regional Medical Center, Advanced Wound Healing Center
  • The Wound Institute and Research Center
  • Armstrong County Wound Healing Center
  • Temple University School of Podiatric Medicine
  • Health Concepts
  • Limb Salvage Centre
  • Complete Family Foot Care
  • Robert Wunderlich, DPM, P.A.
  • University of Texas Health Science Center at San Antonio
  • Endeavor Clinical Trials, PA
  • Trinity Mother Frances Hospitals and Clinics
  • Clinica de Podologia, Ciudad Universitaria
  • Centro de Diagnostico y Tratamiento Francisco Diaz
  • Chang Gung Memorial Hospital
  • Diabetic Foot Clinic, King's College Hospital
  • Manchester Diabetes Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

#1 Medical food

#2 Control

Arm Description

Outcomes

Primary Outcome Measures

Wound healing

Secondary Outcome Measures

QOL
Wound healing measures
Incidence of complications
Clinical outcome data

Full Information

First Posted
June 23, 2008
Last Updated
November 1, 2011
Sponsor
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT00711217
Brief Title
Evaluation of a Medical Food for Chronic Wounds
Official Title
Evaluation of a Medical Food for Chronic Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
#1 Medical food
Arm Type
Experimental
Arm Title
#2 Control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Medical Food
Other Intervention Name(s)
AN0806A
Intervention Description
twice daily
Intervention Type
Other
Intervention Name(s)
Drink mix calorically similar to experimental product
Other Intervention Name(s)
AN0806B
Intervention Description
twice daily
Primary Outcome Measure Information:
Title
Wound healing
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
QOL
Time Frame
16 weeks
Title
Wound healing measures
Time Frame
16 weeks
Title
Incidence of complications
Time Frame
16 weeks
Title
Clinical outcome data
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Voss, PhD, RD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3360
Country
United States
Facility Name
Biomedical Research and Educational Foundation of Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Foot and Ankle Specialist
City
Brawley
State/Province
California
ZIP/Postal Code
92227
Country
United States
Facility Name
Center for Clinical Research, Inc
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Central Coast Foot and Ankle
City
Freedom
State/Province
California
ZIP/Postal Code
95019
Country
United States
Facility Name
Foot and Ankle Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Facility Name
California School of Podiatric Medicine at Samuel Merritt University
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Advanced Clinical Research
City
San Jose
State/Province
California
ZIP/Postal Code
95116
Country
United States
Facility Name
Pacific Wound Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Precision Foot and Ankle Centers - Torrance
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Diabetic Foot and Wound Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
McHugh & Associates
City
Watertown
State/Province
Connecticut
ZIP/Postal Code
06795
Country
United States
Facility Name
Doctor's Research Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
SCORE Physician Alliance
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
South Florida Wound Care Group
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Ankle and Foot Associates
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Aiyan Diabetes Center
City
Evans
State/Province
Georgia
ZIP/Postal Code
30809
Country
United States
Facility Name
Garrett Noguchi, DPM, P.A.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Rosalind Franklin University, Center for Lower Extremity Ambulatory Research
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Amputation Prevention Center Broadlawns Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Christus Schumpert Wound Care Center & Hyperbaric Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Chesapeake Research Group
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
Foot Care, Endovascular and Vascular Services Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center, Harvard University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
American Center for Clinical Trials
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Foot Healthcare Associates
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Advance Foot & Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
VA Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Gerard J. Furst, DPM, PLLC
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Akron General Medical Center, The Wound Care Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
St. Vincent Charity Hospital, Wound Care Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
ProMedica Health Systems
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Blair Medical Associates, Inc.
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Carlisle Regional Medical Center, Advanced Wound Healing Center
City
Carlisle
State/Province
Pennsylvania
ZIP/Postal Code
17015
Country
United States
Facility Name
The Wound Institute and Research Center
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
Armstrong County Wound Healing Center
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States
Facility Name
Temple University School of Podiatric Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Limb Salvage Centre
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Complete Family Foot Care
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Facility Name
Robert Wunderlich, DPM, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Endeavor Clinical Trials, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Trinity Mother Frances Hospitals and Clinics
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Clinica de Podologia, Ciudad Universitaria
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Centro de Diagnostico y Tratamiento Francisco Diaz
City
Madrid
ZIP/Postal Code
28806
Country
Spain
Facility Name
Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
Diabetic Foot Clinic, King's College Hospital
City
London
Country
United Kingdom
Facility Name
Manchester Diabetes Centre
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Medical Food for Chronic Wounds

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