NCT03995407

Brief Summary

This study seeks to evaluate if a 100% whey protein based diet enhances pressure ulcer healing.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

June 21, 2019

Last Update Submit

March 15, 2021

Conditions

Pressure Ulcer

Keywords

Pressure ulcerWhey proteinWound healing

Outcome Measures

Primary Outcomes (2)

  • Percentage Reduction in Wound Surface Area

    Percentage reduction in wound surface area = \[Surface area at baseline - Surface area after 4 weeks\] / \[Surface area at baseline\] %

    4 weeks

  • Pressure Ulcer Score for Healing (PUSH) Score

    The Pressure Ulcer Scale for Healing (PUSH Tool) was developed by the National Pressure Ulcer Advisory Panel (NPUAP) as a quick, reliable tool to monitor the change in pressure ulcer status over time. The total score ranges from 0 (best condition) to 17 (worst condition) and is derived from 3 parameters (product of length and width of wound, exudate amount, and tissue type).

    4 weeks

Secondary Outcomes (1)

  • Amount of Peptamen® and Beneprotein® consumed

    4 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants in the control arm will receive "usual care".

Other: Usual Care

100% Whey Protein

EXPERIMENTAL

Participants will receive 100% Whey Protein oral nutritional supplements.

Dietary Supplement: Peptamen®

Interventions

Peptamen®DIETARY_SUPPLEMENT

Participants in the intervention arm will be categorised into those who are not currently taking oral nutritional supplement and those who are currently on oral nutritional supplements. Those who are not currently taking oral nutritional supplement will be started on Peptamen® while those who are currently on oral nutritional supplements will have to convert to Peptamen® solely. The dietician will determine the amount of Peptamen® required per day based on the recommendations of the product information. Should the participant's daily protein requirement not be met be Peptamen® alone, the dietician will recommend additional whey protein to be added in the form of Beneprotein® Instant Protein Powder. Beneprotein® is a concentrated source of high-quality whey protein that can be added to most foods, liquids or enteral formulas.

100% Whey Protein
Usual CareOTHER

Participants receive "usual care". They will be categorised into those who are not currently taking oral nutritional supplement and those who are currently on oral nutritional supplements (non-100% whey i.e. not on Peptamen® or Beneprotein®). They will consume their regular diet in accordance with the dietician's recommendations.

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any age, gender or ethnicity.
  • Admitted for subacute wound care.
  • Diagnosed with stage 3 or 4 pressure ulcer.
  • Wound surface area \> 4cm2.

You may not qualify if:

  • Prognosis of less than 1 year.
  • Diagnosed with osteomyelitis of the wound.
  • Allergy to soy or corn.
  • Chronic Kidney Disease Stage 4 or 5.
  • Participants who are already consuming oral nutritional supplements and are not willing to convert to Peptamen® if allocated to the intervention arm.
  • Participants who are currently consuming Peptamen® or another 100% whey protein oral nutritional supplement.
  • Dislikes the taste of milk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luke's Hospital

Singapore, 659674, Singapore

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Peptamen

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeffrey Jiang Song'en, MBBS

    St. Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel 2-arm pilot randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2019

First Posted

June 24, 2019

Study Start

June 20, 2019

Primary Completion

January 20, 2021

Study Completion

January 20, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)