NCT01107197

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 12, 2014

Completed
Last Updated

February 12, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

April 15, 2010

Results QC Date

March 10, 2013

Last Update Submit

January 16, 2014

Conditions

Pressure Ulcers

Keywords

Pressure ulcersHealingMalnutritionNutritional supportMicronutrients

Outcome Measures

Primary Outcomes (1)

  • Rate of Healing

    healing is defined as reduction in ulcer area (the percentage of change)

    8 weeks of nutritional support (baseline and week 8)

Secondary Outcomes (6)

  • Rate of Healing

    8 weeks of nutritional support (baseline and week 8)

  • Rate of Healing

    8 weeks of nutritional support (baseline and week 8)

  • Incidence of Infections

    8 weeks of nutritional support (baseline and week 8)

  • Cost-effectiveness

    8 weeks of nutritional support (baseline and week 8)

  • Dressings

    8 weeks of nutritional support (baseline and week 8)

  • +1 more secondary outcomes

Study Arms (2)

Isonitrogenous isocaloric formula

ACTIVE COMPARATOR

Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one

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

Dietary Supplement: Enriched nutrition formula

Interventions

Enriched nutrition formulaDIETARY_SUPPLEMENT

oral formula enriched in arginine, zinc and antioxidant oligoelements

Also known as: Cubitan (NUTRICIA Italia)
Enriched nutrition formula
Control formulaDIETARY_SUPPLEMENT

Isonitrogenous isocaloric oral formula

Isonitrogenous isocaloric formula

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, 28100, Italy

Location

Related Publications (6)

  • 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.

    PMID: 19563522BACKGROUND

  • Benati 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.

    PMID: 11431045BACKGROUND

  • Frias 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.

    PMID: 15469215BACKGROUND

  • Heyman 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.

    PMID: 18978686BACKGROUND

  • van 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.

    PMID: 20598855BACKGROUND

  • Cereda 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.

    PMID: 25643304DERIVED

MeSH Terms

Conditions

Pressure UlcerMalnutrition

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesNutrition DisordersNutritional and Metabolic Diseases

Limitations and Caveats

Limited to specific settings: long-term care and home-care services Limited to malnourished patients

Results Point of Contact

Title
Dr. Federico D'Andrea
Organization
Department of Clinical Nutrition and Dietetics, Azienda Ospedaliera "Maggiore della Carità"
dietologia@maggioreosp.novara.it
+39 0321.373.3275

Study Officials

  • Federico D'Andrea, MD

    Azienda Ospedaliero Universitaria Maggiore della Carita

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Nutrition Unit

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 20, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 12, 2014

Results First Posted

February 12, 2014

Record last verified: 2014-01

Locations

IT(1)