Nutritional Support in Pressure Ulcer Patients (OEST)

January 16, 2014 updated by: FEDERICO D'ANDREA, Azienda Ospedaliero Universitaria Maggiore della Carita

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • Azienda Ospedaliero Universitaria Maggiore della Carità

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Cubitan (NUTRICIA Italia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks of nutritional support (baseline and week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Healing
Time Frame: 8 weeks of nutritional support (baseline and week 8)
reduction in ulcer area >=40%
8 weeks of nutritional support (baseline and week 8)
Rate of Healing
Time Frame: 8 weeks of nutritional support (baseline and week 8)
complete healing
8 weeks of nutritional support (baseline and week 8)
Incidence of Infections
Time Frame: 8 weeks of nutritional support (baseline and week 8)
defined as local (ulcer)
8 weeks of nutritional support (baseline and week 8)
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).
8 weeks of nutritional support (baseline and week 8)
Dressings
Time Frame: 8 weeks of nutritional support (baseline and week 8)
The number of dressings used throughout the intervention period
8 weeks of nutritional support (baseline and week 8)
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
4 weeks of nutritional support (baseline and week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Collaborators

Nutricia, Inc.

Investigators

  • Principal Investigator: Federico D'Andrea, MD, Azienda Ospedaliero Universitaria Maggiore della Carità

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (ESTIMATE)

April 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 473/CE (Study n° CE 61/07)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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