Trials / Completed
CompletedNCT01107197
Nutritional Support in Pressure Ulcer Patients
Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Enriched nutrition formula | oral formula enriched in arginine, zinc and antioxidant oligoelements |
| DIETARY_SUPPLEMENT | Control formula | Isonitrogenous isocaloric oral formula |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2010-04-20
- Last updated
- 2014-02-12
- Results posted
- 2014-02-12
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01107197. Inclusion in this directory is not an endorsement.