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100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995407
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
JIANG SONG'EN, JEFFREY, St Luke's Hospital, Singapore

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

Condition or disease Intervention/treatment Phase
Pressure Ulcer Dietary Supplement: Peptamen® Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel 2-arm pilot randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing- A Pilot Randomized Controlled Trial.
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Active Comparator: Control
Participants in the control arm will receive "usual care".
Other: Usual Care
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.

Experimental: 100% Whey Protein
Participants will receive 100% Whey Protein oral nutritional supplements.
Dietary Supplement: Peptamen®
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.




Primary Outcome Measures :
  1. Percentage Reduction in Wound Surface Area [ Time Frame: 4 weeks ]
    Percentage reduction in wound surface area = [Surface area at baseline - Surface area after 4 weeks] / [Surface area at baseline] %

  2. Pressure Ulcer Score for Healing (PUSH) Score [ Time Frame: 4 weeks ]
    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).


Secondary Outcome Measures :
  1. Amount of Peptamen® and Beneprotein® consumed [ Time Frame: 4 weeks ]
    Measured in grams.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995407


Contacts
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Contact: Jeffrey Jiang Song'en, MBBS +65-66977565 jeffreyjiang@stluke.org.sg
Contact: Kavitha D/O Sanmugam, MN +65-68953260 kavithasanmugam@stluke.org.sg

Locations
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Singapore
St Luke's Hospital Recruiting
Singapore, Singapore, 659674
Sponsors and Collaborators
St Luke's Hospital, Singapore
Investigators
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Principal Investigator: Jeffrey Jiang Song'en, MBBS St. Luke's Hospital
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Responsible Party: JIANG SONG'EN, JEFFREY, Principal Investigator, St Luke's Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03995407    
Other Study ID Numbers: IRB-03-2019-01-03
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JIANG SONG'EN, JEFFREY, St Luke's Hospital, Singapore:
Pressure ulcer
Whey protein
Wound healing
Additional relevant MeSH terms:
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Pressure Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases