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OpenTrials
Completed

NCT Number: NCT00711217

Evaluation of a Medical Food for Chronic Wounds

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.

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Key information

Conditions

Foot Ulcer, Diabetic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Diagnostico y Tratamiento Francisco Diaz, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Food

Other

twice daily

Other names: AN0806A

Drink mix calorically similar to experimental product

Other

twice daily

Other names: AN0806B

Primary outcomes

  1. Wound healing

    Time frame: 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 8, 2008
Registry last updated
Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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