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Evaluation of a Medical Food for Chronic Wounds
This study is currently recruiting participants.
Verified by Abbott Nutrition, January 2009
First Received: June 23, 2008   Last Updated: January 2, 2009   History of Changes
Sponsored by: Abbott Nutrition
Information provided by: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00711217
  Purpose

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.


Condition Intervention Phase
Foot Ulcer, Diabetic
 Other: Medical Food
Other: Drink mix calorically similar to experimental product
 Phase III

MedlinePlus related topics: Diabetic Foot Foot Health
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Evaluation of a Medical Food for Chronic Wounds

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Wound healing [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QOL [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Wound healing measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of complications [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Clinical outcome data [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 248
Study Start Date: June 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
#1 Medical food: Experimental Other: Medical Food
twice daily
#2 Control: Placebo Comparator Other: Drink mix calorically similar to experimental product
twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711217

Contacts
Contact: Bobbie L Swearengin, RN 614-624-7182 Bobbie.Swearengin@abbott.com

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294-3360
Principal Investigator: Andres Julian Munoz, MD            
United States, Colorado
Diabetic Foot and Wound Center Recruiting
Denver, Colorado, United States, 80220
Principal Investigator: Eric Jaakola, DPM            
United States, Florida
Doctor's Research Network Recruiting
Miami, Florida, United States, 33143
Principal Investigator: Jason Hanft, DPM            
United States, Iowa
Amputation Prevention Center Broadlawns Medical Center Recruiting
Des Moines, Iowa, United States, 50314
Principal Investigator: Lee C Rogers, DPM            
United States, Massachusetts
Foot Care, Endovascular and Vascular Services Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Vickie Driver, DPM, FACFAS            
United States, Nevada
VA Medical Center Recruiting
Reno, Nevada, United States, 89502
Principal Investigator: Patricia May, MD            
United States, New York
North Shore Podiatry Group Recruiting
Port Jefferson Station, New York, United States, 11776
Principal Investigator: Gerald Furst, DPM            
United States, Ohio
The Wound Care Center Recruiting
Akron, Ohio, United States, 44307
Principal Investigator: Amy Tucker, MD            
ProMedica Health Systems Recruiting
Toledo, Ohio, United States, 43606
Principal Investigator: Matthew Wilkin, DPM            
United States, Pennsylvania
Temple University School of Podiatric Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: James McGuire, MD            
United States, Texas
DCS, Trinity Mother Frances Hospitals and Clinics Recruiting
Tyler, Texas, United States, 75701
Principal Investigator: Maxine Theriot            
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Director: Anne Voss, PhD, RD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition ( Bobbie Swearengin, Director Clinical Research Operations )
Study ID Numbers: BK15
Study First Received: June 23, 2008
Last Updated: January 2, 2009
ClinicalTrials.gov Identifier: NCT00711217     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
 Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:
Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases
 Diabetic Angiopathies
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on May 07, 2009



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