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MultimorbidityPhase 4NCT06726486

Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores

A Phase 4 study testing Atémpero in people with Multimorbidity and Comorbidity, run by University of Cadiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to evaluate the efficacy of a hypercaloric, hyperproteic enteral formula enriched with immunonutrients in preventing and treating pressure injuries in hospitalized malnourished patients. Read more about this study

Who is it for?
Any age
Conditions the study is for
Multimorbidity, Comorbidity, Malnutrition
What is being tested?
Atémpero
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteSpain
Study dates
1 Jan 2022to 30 Apr 2023
Phase
Phase 4
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Hospitalized chronic patients with complex needs in the Internal Medicine Department of a regional hospital.
  • Malnourished or at risk of malnutrition.
  • Moderate-high risk of developing pressure-related injuries or the presence of pressure-related injuries.

Who cannot join

  • Limitations in oral intake (due to pathologies, state of health, among others).
  • Contraindications for using the oral route and digestive intolerance or allergy to any of the components of the products.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Punta Europa University of Cadiz

    Algeciras, Cadiz, 11207

Other trials in Spain

About this study

Official title: Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores: a Randomized Controlled Trial

The goal of this study is to evaluate the efficacy of a hypercaloric, hyperproteic enteral formula enriched with immunonutrients in preventing and treating pressure injuries in hospitalized malnourished patients.

Participants will take enteral formula (a complete hyperproteic and hypercaloric oral nutritional supplement with a fibre mixture enriched in omega 3, L-arginine and nucleotides, providing vitamin C and Zinc) or a hyperproteic and hypercaloric oral nutritional supplement with fibre mixture every day for 30 days.

Being tested
Atémpero, Control (Standard treatment)
Keywords
Multimorbidity, Comorbidity, Malnutrition, Pressure Ulcer, Supplements, Immunonutrients
Medical subject headings
Malnutrition, Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtémperoDietary supplement

    A complete hyperproteic and hypercaloric diet with a mixture of fibres enriched in omega 3, L-arginine and nucleotides (which provides vitamin C and Zinc) was administered.

  • Control (Standard treatment)Dietary supplement

    A complete high-protein and high-calorie diet with mixed fibre was administered.

Study groups in NCT06726486
Study groupRoleWhat they receive
Intervention Group (Atémpero)ExperimentalParticipants received an arginine-enriched ONS called Atémpero®.
Receives: Dietary Supplement: Atémpero
Control GroupActive comparatorParticipants received a complete high-protein, high-calorie diet with mixed fiber.
Receives: Dietary Supplement: Control (Standard treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of pressure-related injuries

    Dichotomous variable: Yes/No.

    Measured: 15 and 30 days

  2. Risk of developing pressure-related injuries

    Measurement instrument: Braden scale (low risk, moderate risk, high risk).

    Measured: 15 and 30 days

  3. Categorization of pressure-related injuries

    Measurement instrument: PUSH scale (I, II, III, IV).

    Measured: 15 and 30 days

  4. Pressure-related injuries healing

    Measurement instrument: PUSH scale (closed, epithelial tissue, granulation tissue, sphacelium, necrotic tissue).

    Measured: 15 and 30 days

  5. Degree of dependence

    Measurement instruments (description): Barthel score (independent, mild, moderate, severe).

    Measured: 0, 15, and 30 days.

  6. Weight loss

    Measurement instruments (description): Weight scale (kg).

    Measured: 0, 15 and 30 days.

  7. % of dietary intake

    0%, 25%, 50%, 75%, 100% intake.

    Measured: 15 and 30 days.

  8. ONS adherence

    0%, 25%, 50%, 75%, 100% intake.

    Measured: 15 and 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start1 Jan 2022
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A single-blind parallel Randomized Controlled Clinical Trial.
Masking
Single blind
Who is masked
Investigator
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06726486
Sponsor's protocol ID
84.21
Status last verified
Dec 2024
First submitted
4 Dec 2024
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data will be available after publication of the study results.

Publications

  • Liu P, Shen WQ, Chen HL. Efficacy of arginine-enriched enteral formulas for the healing of pressure ulcers: a systematic review. J Wound Care. 2017 Jun 2;26(6):319-323. doi: 10.12968/jowc.2017.26.6.319.

    PubMed 28598762

  • Barchitta M, Maugeri A, Favara G, Magnano San Lio R, Evola G, Agodi A, Basile G. Nutrition and Wound Healing: An Overview Focusing on the Beneficial Effects of Curcumin. Int J Mol Sci. 2019 Mar 5;20(5):1119. doi: 10.3390/ijms20051119.

    PubMed 30841550

  • Cheshmeh S, Hojati N, Mohammadi A, Rahmani N, Moradi S, Pasdar Y, Elahi N. The use of oral and enteral tube-fed arginine supplementation in pressure injury care: A systematic review and meta-analysis. Nurs Open. 2022 Nov;9(6):2552-2561. doi: 10.1002/nop2.974. Epub 2021 Jun 25.

    PubMed 34170617

  • Yatabe J, Saito F, Ishida I, Sato A, Hoshi M, Suzuki K, Kameda T, Ueno S, Yatabe MS, Watanabe T, Sanada H. Lower plasma arginine in enteral tube-fed patients with pressure ulcer and improved pressure ulcer healing after arginine supplementation by Arginaid Water. J Nutr Health Aging. 2011 Apr;15(4):282-6. doi: 10.1007/s12603-010-0306-4.

    PubMed 21437560

  • Roberts S, Chaboyer W, Desbrow B. Nutrition care-related practices and factors affecting nutritional intakes in hospital patients at risk of pressure ulcers. J Hum Nutr Diet. 2015 Aug;28(4):357-65. doi: 10.1111/jhn.12258. Epub 2014 Jun 27.

    PubMed 24974729

  • Eglseer D, Hodl M, Lohrmann C. Nutritional management of older hospitalised patients with pressure injuries. Int Wound J. 2019 Feb;16(1):226-232. doi: 10.1111/iwj.13016. Epub 2018 Nov 15.

    PubMed 30440105

  • Volkert D, Beck AM, Cederholm T, Cruz-Jentoft A, Hooper L, Kiesswetter E, Maggio M, Raynaud-Simon A, Sieber C, Sobotka L, van Asselt D, Wirth R, Bischoff SC. ESPEN practical guideline: Clinical nutrition and hydration in geriatrics. Clin Nutr. 2022 Apr;41(4):958-989. doi: 10.1016/j.clnu.2022.01.024. Epub 2022 Mar 5.

    PubMed 35306388

  • Langer G, Wan CS, Fink A, Schwingshackl L, Schoberer D. Nutritional interventions for preventing and treating pressure ulcers. Cochrane Database Syst Rev. 2024 Feb 12;2(2):CD003216. doi: 10.1002/14651858.CD003216.pub3.

    PubMed 38345088

  • Mervis JS, Phillips TJ. Pressure ulcers: Prevention and management. J Am Acad Dermatol. 2019 Oct;81(4):893-902. doi: 10.1016/j.jaad.2018.12.068. Epub 2019 Jan 18.

    PubMed 30664906

  • Banks MD, Ross LJ, Webster J, Mudge A, Stankiewicz M, Dwyer K, Coleman K, Campbell J. Pressure ulcer healing with an intensive nutrition intervention in an acute setting: a pilot randomised controlled trial. J Wound Care. 2016 Jul 2;25(7):384-92. doi: 10.12968/jowc.2016.25.7.384.

    PubMed 27410392

  • Clark RK, Stampas A, Kerr KW, Nelson JL, Sulo S, Leon-Novelo L, Ngan E, Pandya D. Evaluating the impact of using a wound-specific oral nutritional supplement to support wound healing in a rehabilitation setting. Int Wound J. 2023 Jan;20(1):145-154. doi: 10.1111/iwj.13849. Epub 2022 Jun 9.

    PubMed 35684975

  • Wood J, Brown B, Bartley A, Margarida Batista Custodio Cavaco A, Roberts AP, Santon K, Cook S. Reducing pressure ulcers across multiple care settings using a collaborative approach. BMJ Open Qual. 2019 Aug 20;8(3):e000409. doi: 10.1136/bmjoq-2018-000409. eCollection 2019.

    PubMed 31523723

  • Stracci G, Scarpellini E, Rinninella E, Mignini EV, Clementi N, Boni MV, Valeri MV, Sansoni D, Abenavoli L, Gasbarrini A, Rasetti C, Santori P. Effects of enteral nutrition on patients with pressure lesions: a single center, pilot study. Eur Rev Med Pharmacol Sci. 2020 Feb;24(3):1563-1570. doi: 10.26355/eurrev_202002_20214.

    PubMed 32096205

  • Wung Buh A, Mahmoud H, Chen W, McInnes MDF, Fergusson DA. Effects of implementing Pressure Ulcer Prevention Practice Guidelines (PUPPG) in the prevention of pressure ulcers among hospitalised elderly patients: a systematic review protocol. BMJ Open. 2021 Mar 12;11(3):e043042. doi: 10.1136/bmjopen-2020-043042.

    PubMed 33712523

  • Jaul E, Barron J, Rosenzweig JP, Menczel J. An overview of co-morbidities and the development of pressure ulcers among older adults. BMC Geriatr. 2018 Dec 11;18(1):305. doi: 10.1186/s12877-018-0997-7.

    PubMed 30537947

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atémpero in people with Multimorbidity and Comorbidity, run by University of Cadiz at 1 site in Spain.

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 3 inclusion and 2 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 10 Dec 2024. 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 Spain. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Presence of pressure-related injuries (time frame: 15 and 30 days). The study lists 8 primary outcomes in all. 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 NCT06726486, which also lists 23 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 10 Dec 2024.

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