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Completed

NCT Number: NCT01107197

Nutritional Support in Pressure Ulcer Patients

Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. Moreover, other investigators have suggested the additional healing power of some nutrients. Unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. The investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.

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Key information

Conditions

Pressure Ulcers Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, 28100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient or legal guardian or caregiver consent
  • stage II, III or IV pressure ulcers
  • malnutrition (as defined by low body mass index and/or unintentional weight loss and/or low serum albumin and/or reduced food intake [<60% of total daily estimated requirements])
  • patients who can drink supplements
  • home-care or long-term care

Exclusion criteria

  • decompensated diabetes (HbA1C >7%)
  • renal failure
  • hepatic failure (Child B and C)
  • current neoplastic disease
  • any organ-failure
  • immunosuppressive therapy
  • connective tissue disease
  • use of steroids
  • obesity
  • respiratory insufficiency (COPD)
  • anemia (haemoglobin <10g/dL)
  • previous neoplastic disease (<1 year since last treatment CT or RT)
  • infected wounds
  • cellulitis, sepsis or osteomyelitis
  • poor tolerance to sip feeding

Treatment and study plan

Enriched nutrition formula

Dietary Supplement

oral formula enriched in arginine, zinc and antioxidant oligoelements

Other names: Cubitan (NUTRICIA Italia)

Control Formula

Dietary Supplement

Isonitrogenous isocaloric oral formula

Primary outcomes

  1. Rate of Healing

    Time frame: 8 weeks of nutritional support (baseline and week 8)

    healing is defined as reduction in ulcer area (the percentage of change)

Secondary outcomes

  1. Rate of Healing

    Time frame: 8 weeks of nutritional support (baseline and week 8)

    reduction in ulcer area >=40%

  2. Rate of Healing

    Time frame: 8 weeks of nutritional support (baseline and week 8)

    complete healing

  3. Incidence of Infections

    Time frame: 8 weeks of nutritional support (baseline and week 8)

    defined as local (ulcer)

  4. Cost-effectiveness

    Time frame: 8 weeks of nutritional support (baseline and week 8)

    Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active - control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy).

  5. Dressings

    Time frame: 8 weeks of nutritional support (baseline and week 8)

    The number of dressings used throughout the intervention period

  6. the Percentage of Change in Area

    Time frame: 4 weeks of nutritional support (baseline and week 4)

    the reduction in ulcer area (%) observed at 4 weeks

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Collaborators

  • Nutricia, Inc.

Registry information

Official study title

Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)

Acronym: OEST

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2010
Registry last updated
Feb 12, 2014

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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