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Nutritional Support in Pressure Ulcer Patients (OEST)

This study has been completed.
Sponsor:
Collaborator:
NUTRICIA Italia
Information provided by (Responsible Party):
FEDERICO D'ANDREA, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT01107197
First received: April 15, 2010
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • rate of healing [ Time Frame: 8 weeks of nutritional support ] [ Designated as safety issue: No ]
    healing is defined as complete healing or reduction in ulcer area as continuous and categorical variable (>=40%)


Secondary Outcome Measures:
  • reduction in costs of care [ Time Frame: 8 weeks of nutritional support ] [ Designated as safety issue: No ]
    costs analyses are based on antiobiotics therapy (days, dose and type of medication), number and type of dressing throughout the study, number of additional (out of those scheduled in the protocol) visits by healthcare professionals

  • incidence of infections [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    defined as local (ulcer)


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 bricks 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 two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant vitamins
 Dietary Supplement: Enriched nutrition formula
oral formula enriched in arginine, zinc and antioxidant vitamins
Other Name: Cubitan (NUTRICIA Italia)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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)
  • patients who can drink supplement
  • home-care or long-term care
  • reduced food intake (<60% of total daily estimated requirements)

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

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)
Study First Received: April 15, 2010
Last Updated: January 2, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
Pressure ulcers
Healing
Malnutrition
Nutritional support
Micronutrients

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

ClinicalTrials.gov processed this record on May 23, 2013