Pressure UlcersOESTNCT01107197
Nutritional Support in Pressure Ulcer Patients
A study testing Enriched nutrition formula in people with Pressure Ulcers, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Enriched nutrition formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- decompensated diabetes (HbA1C >7%)
- renal failure
- hepatic failure (Child B and C)
- current neoplastic disease
- any organ-failure
- immunosuppressive therapy
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, 28100
About this study
Official title: 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.
- Conditions
- Pressure Ulcers
- Being tested
- Enriched nutrition formula, Control formula
- Keywords
- Pressure ulcers, Healing, Malnutrition, Nutritional support, Micronutrients
- Medical subject headings
- Pressure Ulcer, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched nutrition formulaDietary supplement
Also called Cubitan (NUTRICIA Italia)
oral formula enriched in arginine, zinc and antioxidant oligoelements
Control formulaDietary supplement
Isonitrogenous isocaloric oral formula
| Study group | Role | What they receive |
|---|---|---|
| Isonitrogenous isocaloric formula | Active comparator | Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one Receives: Dietary Supplement: Control formula |
| Enriched nutrition formula | Experimental | Patients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements Receives: Dietary Supplement: Enriched nutrition formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Healing
healing is defined as reduction in ulcer area (the percentage of change)
Measured: 8 weeks of nutritional support (baseline and week 8)
Secondary outcomes (6)
Rate of Healing
reduction in ulcer area >=40%
Measured: 8 weeks of nutritional support (baseline and week 8)
Rate of Healing
complete healing
Measured: 8 weeks of nutritional support (baseline and week 8)
Incidence of Infections
defined as local (ulcer)
Measured: 8 weeks of nutritional support (baseline and week 8)
Cost-effectiveness
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).
Measured: 8 weeks of nutritional support (baseline and week 8)
Dressings
The number of dressings used throughout the intervention period
Measured: 8 weeks of nutritional support (baseline and week 8)
the Percentage of Change in Area
the reduction in ulcer area (%) observed at 4 weeks
Measured: 4 weeks of nutritional support (baseline and week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia, Inc.
- Responsible party
- Principal investigator, FEDERICO D'ANDREA, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Federico D'Andrea, MD, Principal investigator, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107197
- Sponsor's protocol ID
- 473/CE (Study n° CE 61/07)
- Acronym
- OEST
- Status last verified
- Jan 2014
- First submitted
- 15 Apr 2010
- Last updated
- 12 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25.
PubMed 19563522Benati G, Delvecchio S, Cilla D, Pedone V. Impact on pressure ulcer healing of an arginine-enriched nutritional solution in patients with severe cognitive impairment. Arch Gerontol Geriatr Suppl. 2001;7:43-7. doi: 10.1016/s0167-4943(01)00120-0. No abstract available.
PubMed 11431045Frias Soriano L, Lage Vazquez MA, Maristany CP, Xandri Graupera JM, Wouters-Wesseling W, Wagenaar L. The effectiveness of oral nutritional supplementation in the healing of pressure ulcers. J Wound Care. 2004 Sep;13(8):319-22. doi: 10.12968/jowc.2004.13.8.26654.
PubMed 15469215Heyman H, Van De Looverbosch DE, Meijer EP, Schols JM. Benefits of an oral nutritional supplement on pressure ulcer healing in long-term care residents. J Wound Care. 2008 Nov;17(11):476-8, 480. doi: 10.12968/jowc.2008.17.11.31475.
PubMed 18978686van Anholt RD, Sobotka L, Meijer EP, Heyman H, Groen HW, Topinkova E, van Leen M, Schols JM. Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. Nutrition. 2010 Sep;26(9):867-72. doi: 10.1016/j.nut.2010.05.009. Epub 2010 Jul 3.
PubMed 20598855Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696.
PubMed 25643304
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)
- ClinicalTrials.gov ID
- NCT01107197
- Acronym / sponsor ID
- OEST / 473/CE (Study n° CE 61/07)
- Conditions
- Pressure Ulcers
- Keywords
- Pressure ulcers, Healing, Malnutrition, Nutritional support, Micronutrients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Collaborators
- Nutricia, Inc.
- Study start
- Feb 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Posted 12 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isonitrogenous isocaloric formula | Active comparator | Dietary Supplement: Control formulaPatients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one |
| Enriched nutrition formula | Experimental | Dietary Supplement: Enriched nutrition formulaPatients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- decompensated diabetes (HbA1C >7%)
- renal failure
- hepatic failure (Child B and C)
- current neoplastic disease
- any organ-failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enriched nutrition formulaAlso: Cubitan (NUTRICIA Italia)oral formula enriched in arginine, zinc and antioxidant oligoelements | Dietary supplement | Enriched nutrition formula |
| Control formulaIsonitrogenous isocaloric oral formula | Dietary supplement | Isonitrogenous isocaloric formula |
Primary outcome
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)
6 secondary outcomes
Rate of Healing
Time frame: 8 weeks of nutritional support (baseline and week 8)
Rate of Healing
Time frame: 8 weeks of nutritional support (baseline and week 8)
Incidence of Infections
Time frame: 8 weeks of nutritional support (baseline and week 8)
Cost-effectiveness
Time frame: 8 weeks of nutritional support (baseline and week 8)
Dressings
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19563522Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25.
- Background: PubMed 11431045Benati G, Delvecchio S, Cilla D, Pedone V. Impact on pressure ulcer healing of an arginine-enriched nutritional solution in patients with severe cognitive impairment. Arch Gerontol Geriatr Suppl. 2001;7:43-7. doi: 10.1016/s0167-4943(01)00120-0. No abstract available.
- Background: PubMed 15469215Frias Soriano L, Lage Vazquez MA, Maristany CP, Xandri Graupera JM, Wouters-Wesseling W, Wagenaar L. The effectiveness of oral nutritional supplementation in the healing of pressure ulcers. J Wound Care. 2004 Sep;13(8):319-22. doi: 10.12968/jowc.2004.13.8.26654.
- Background: PubMed 18978686Heyman H, Van De Looverbosch DE, Meijer EP, Schols JM. Benefits of an oral nutritional supplement on pressure ulcer healing in long-term care residents. J Wound Care. 2008 Nov;17(11):476-8, 480. doi: 10.12968/jowc.2008.17.11.31475.
- Background: PubMed 20598855van Anholt RD, Sobotka L, Meijer EP, Heyman H, Groen HW, Topinkova E, van Leen M, Schols JM. Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. Nutrition. 2010 Sep;26(9):867-72. doi: 10.1016/j.nut.2010.05.009. Epub 2010 Jul 3.
- Derived from this study: PubMed 25643304Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico D'Andrea, MD principal investigator
Azienda Ospedaliero Universitaria Maggiore della Carita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched nutrition formula in people with Pressure Ulcers, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Healing (time frame: 8 weeks of nutritional support (baseline and week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107197, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.