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Evaluation of a Medical Food for Chronic Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00711217
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Other: Medical Food Other: Drink mix calorically similar to experimental product Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Medical Food for Chronic Wounds
Study Start Date : June 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: #1 Medical food Other: Medical Food
twice daily
Other Name: AN0806A
Placebo Comparator: #2 Control Other: Drink mix calorically similar to experimental product
twice daily
Other Name: AN0806B


Outcome Measures

Primary Outcome Measures :
  1. Wound healing [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. QOL [ Time Frame: 16 weeks ]
  2. Wound healing measures [ Time Frame: 16 weeks ]
  3. Incidence of complications [ Time Frame: 16 weeks ]
  4. Clinical outcome data [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711217


  Show 51 Study Locations
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Director: Anne Voss, PhD, RD Abbott Nutrition
More Information

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00711217     History of Changes
Other Study ID Numbers: BK15
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: May 2011

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