Evaluation of a Medical Food for Chronic Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00711217
First received: June 23, 2008
Last updated: November 1, 2011
Last verified: May 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of a Medical Food for Chronic Wounds

Resource links provided by NLM:


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 ]

Enrollment: 271
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711217

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

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00711217     History of Changes
Other Study ID Numbers: BK15
Study First Received: June 23, 2008
Last Updated: November 1, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014