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Nutritional Support in Pressure Ulcer Patients (OEST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01107197
First Posted: April 20, 2010
Last Update Posted: February 12, 2014
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.
Collaborator:
NUTRICIA Italia
Information provided by (Responsible Party):
FEDERICO D'ANDREA, Azienda Ospedaliero Universitaria Maggiore della Carita
  Purpose
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.

Condition Intervention
Pressure Ulcers Dietary Supplement: Enriched nutrition formula Dietary Supplement: Control formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)

Resource links provided by NLM:


Further study details as provided by FEDERICO D'ANDREA, Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Rate of Healing [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]
    reduction in ulcer area >=40%

  • Rate of Healing [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]
    complete healing

  • Incidence of Infections [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]
    defined as local (ulcer)

  • 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).

  • Dressings [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]
    The number of dressings used throughout the intervention period

  • 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


Enrollment: 200
Study Start Date: February 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Isonitrogenous isocaloric formula
Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Dietary Supplement: Control formula
Isonitrogenous isocaloric oral formula
Experimental: Enriched nutrition formula
Patients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements
Dietary Supplement: Enriched nutrition formula
oral formula enriched in arginine, zinc and antioxidant oligoelements
Other Name: Cubitan (NUTRICIA Italia)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01107197


Locations
Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
NUTRICIA Italia
Investigators
Principal Investigator: Federico D'Andrea, MD Azienda Ospedaliero Universitaria Maggiore della Carita
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: FEDERICO D'ANDREA, Director of Clinical Nutrition Unit, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01107197     History of Changes
Other Study ID Numbers: 473/CE (Study n° CE 61/07)
First Submitted: April 15, 2010
First Posted: April 20, 2010
Results First Submitted: March 10, 2013
Results First Posted: February 12, 2014
Last Update Posted: February 12, 2014
Last Verified: January 2014

Keywords provided by FEDERICO D'ANDREA, Azienda Ospedaliero Universitaria Maggiore della Carita:
Pressure ulcers
Healing
Malnutrition
Nutritional support
Micronutrients

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases


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