Pressure UlcerNCT03995407
100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing.
A study testing Peptamen® in people with Pressure Ulcer, run by St Luke's Hospital, Singapore at 1 site in Singapore.
Trial summary
This study seeks to evaluate if a 100% whey protein based diet enhances pressure ulcer healing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Peptamen®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Jun 2019to 20 Jan 2021
- Phase
- Interventional
- 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
- Any age, gender or ethnicity.
- Admitted for subacute wound care.
- Diagnosed with stage 3 or 4 pressure ulcer.
- Wound surface area > 4cm2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing- A Pilot Randomized Controlled Trial.
This study seeks to evaluate if a 100% whey protein based diet enhances pressure ulcer healing.
Read the detailed description
A pressure ulcer is defined as an area of localized damage to the skin and underlying tissues caused by pressure, shear, friction, and/or a combination of these. The most common sites for pressure ulcers are the sacrum, heels, ischial tuberosities, greater trochanters, and lateral malleoli.
In Singapore, the prevalence of pressure ulcers was 18.1%, while the incidence was 8.1% in a tertiary hospital in Singapore in 2002. With a rapidly ageing population in Singapore, the prevalence of pressure ulcers is expected to increase further.
Pressure ulcers are associated with serious medical complications, prolonged hospital stay and frequent re-admissions. Patients with pressure ulcers generally have significantly poorer physical function, are less able to perform self-care, and are less mobile. A new pressure ulcer is estimated to increase a patient's hospital stay by nearly a factor of five. Furthermore, pressure ulcers are also correlated with more than two fold rates of increased mortality independent of the source of the ulcer. Pressure ulcers are one of the patient safety indicators reflecting quality of life according to the Agency for Healthcare Research and Quality. Besides affecting the quality of life of patients, pressure ulcers are also associated with the increased utilisation of healthcare resources resulting in a high cost burden to healthcare systems worldwide.
Pressure ulcers occur in individuals with limited mobility due to pressure, or pressure in combination with shear, which decreases circulation and causes tissue damage. Elderly patients and patients with specific predisposing conditions such as hip fractures are particularly at risk. In addition, patients whom are malnourished are not only at risk of pressure ulcers but also have impaired wound healing. Patients with pressure ulcers tend to have negative energy balance and current guidelines recommend the assessment of nutritional status when progress for pressure ulcers closure does not occur and the use of oral nutritional supplements when an oral diet is not sufficient to meet requirements. In particular, nutritional care in wound healing should be directed at ensuring adequate supply of proteins and calories. Major guidelines currently recommend a minimum calorie intake of 30-35 kilocalories per kg per day and protein intake of 1.25-1.5g per kg per day for adults with a pressure ulcer who are assessed as being at risk of malnutrition.
Currently, there is paucity of studies demonstrating the effect whey protein has on wound healing in humans. The effect of whey protein on wound healing has only been studied in diabetic rats which has shown to accelerate closure and the healing process of their wounds. It was postulated that the healing property of whey was due to its ability to limit prolonged inflammation (reduction in IL-6, TNF-alpha, IL-1b and IL-10) and elevating the antioxidant defence system (by up-regulating glutathione and superoxide dismutase).
Whey protein comprises of 20% of the protein content in cow's milk as compared to casein which makes up the remainder of 80%. Whey is made up of immunoglobulins, lactoalbumins, lactoferrin, cysteine and other minor proteins. Compared to casein, whey has rapid gut clearance as it is readily absorbed, has higher nutritional value, maintains and increases lean body mass and has shown to have greater muscle protein accrual in the elderly. Moreover, whey has positive immuno-modulatory effects and is able to maintain better glycaemic control in diabetics due to its lower post-prandial glycaemia, greater stimulation of incretin production and direct insulinotropic effect.
At present, Peptamen® is the only product available in Singapore that contains 100% hydrolysed whey protein. It is a commercially available peptide-based diet (classified under "medical foods" by the US Food and Drug Administration) that provides complete nutrition. It is hypoallergenic (lactose- and gluten-free), appropriate for those with gastrointestinal maldigestion and/or malabsorption and can be used for total nutrition support via oral or tube feeding. We hypothesize that a 100% whey protein based diet (Peptamen®) enhances pressure ulcer healing.
- Conditions
- Pressure Ulcer
- Being tested
- Peptamen®, Usual Care
- Keywords
- Pressure ulcer, Whey protein, Wound healing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants in the control arm will receive "usual care". Receives: Other: Usual Care |
| 100% Whey Protein | Experimental | Participants will receive 100% Whey Protein oral nutritional supplements. Receives: Dietary Supplement: Peptamen® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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] %
Measured: 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).
Measured: 4 weeks
Secondary outcomes (1)
Amount of Peptamen® and Beneprotein® consumed
Measured in grams.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start20 Jun 2019
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Why it stopped: Resourcing issues impacted by COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- Model description
- Parallel 2-arm pilot randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Luke's Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIANG SONG'EN, JEFFREY, St Luke's Hospital, Singapore
- Investigators
- Jeffrey Jiang Song'en, MBBS, Principal investigator, St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995407
- Sponsor's protocol ID
- IRB-03-2019-01-03
- Status last verified
- Mar 2021
- First submitted
- 21 Jun 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 100% Whey Protein Based Diet In Enhancing Pressure Ulcer Healing- A Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03995407
- Acronym / sponsor ID
- IRB-03-2019-01-03
- Conditions
- Pressure Ulcer
- Keywords
- Pressure ulcer, Whey protein, Wound healing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resourcing issues impacted by COVID-19 pandemic.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St Luke's Hospital, SingaporeUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to evaluate if a 100% whey protein based diet enhances pressure ulcer healing.
Detailed description
A pressure ulcer is defined as an area of localized damage to the skin and underlying tissues caused by pressure, shear, friction, and/or a combination of these. The most common sites for pressure ulcers are the sacrum, heels, ischial tuberosities, greater trochanters, and lateral malleoli.
In Singapore, the prevalence of pressure ulcers was 18.1%, while the incidence was 8.1% in a tertiary hospital in Singapore in 2002. With a rapidly ageing population in Singapore, the prevalence of pressure ulcers is expected to increase further.
Pressure ulcers are associated with serious medical complications, prolonged hospital stay and frequent re-admissions. Patients with pressure ulcers generally have significantly poorer physical function, are less able to perform self-care, and are less mobile. A new pressure ulcer is estimated to increase a patient's hospital stay by nearly a factor of five. Furthermore, pressure ulcers are also correlated with more than two fold rates of increased mortality independent of the source of the ulcer. Pressure ulcers are one of the patient safety indicators reflecting quality of life according to the Agency for Healthcare Research and Quality. Besides affecting the quality of life of patients, pressure ulcers are also associated with the increased utilisation of healthcare resources resulting in a high cost burden to healthcare systems worldwide.
Pressure ulcers occur in individuals with limited mobility due to pressure, or pressure in combination with shear, which decreases circulation and causes tissue damage. Elderly patients and patients with specific predisposing conditions such as hip fractures are particularly at risk. In addition, patients whom are malnourished are not only at risk of pressure ulcers but also have impaired wound healing. Patients with pressure ulcers tend to have negative energy balance and current guidelines recommend the assessment of nutritional status when progress for pressure ulcers closure does not occur and the use of oral nutritional supplements when an oral diet is not sufficient to meet requirements. In particular, nutritional care in wound healing should be directed at ensuring adequate supply of proteins and calories. Major guidelines currently recommend a minimum calorie intake of 30-35 kilocalories per kg per day and protein intake of 1.25-1.5g per kg per day for adults with a pressure ulcer who are assessed as being at risk of malnutrition.
Currently, there is paucity of studies demonstrating the effect whey protein has on wound healing in humans. The effect of whey protein on wound healing has only been studied in diabetic rats which has shown to accelerate closure and the healing process of their wounds. It was postulated that the healing property of whey was due to its ability to limit prolonged inflammation (reduction in IL-6, TNF-alpha, IL-1b and IL-10) and elevating the antioxidant defence system (by up-regulating glutathione and superoxide dismutase).
Whey protein comprises of 20% of the protein content in cow's milk as compared to casein which makes up the remainder of 80%. Whey is made up of immunoglobulins, lactoalbumins, lactoferrin, cysteine and other minor proteins. Compared to casein, whey has rapid gut clearance as it is readily absorbed, has higher nutritional value, maintains and increases lean body mass and has shown to have greater muscle protein accrual in the elderly. Moreover, whey has positive immuno-modulatory effects and is able to maintain better glycaemic control in diabetics due to its lower post-prandial glycaemia, greater stimulation of incretin production and direct insulinotropic effect.
At present, Peptamen® is the only product available in Singapore that contains 100% hydrolysed whey protein. It is a commercially available peptide-based diet (classified under "medical foods" by the US Food and Drug Administration) that provides complete nutrition. It is hypoallergenic (lactose- and gluten-free), appropriate for those with gastrointestinal maldigestion and/or malabsorption and can be used for total nutrition support via oral or tube feeding. We hypothesize that a 100% whey protein based diet (Peptamen®) enhances pressure ulcer healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel 2-arm pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Usual CareParticipants in the control arm will receive "usual care". |
| 100% Whey Protein | Experimental | Dietary Supplement: Peptamen®Participants will receive 100% Whey Protein oral nutritional supplements. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any age, gender or ethnicity.
- Admitted for subacute wound care.
- Diagnosed with stage 3 or 4 pressure ulcer.
- Wound surface area > 4cm2.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| 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. | Dietary supplement | 100% Whey Protein |
| Usual CareParticipants 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. | Other | Control |
Primary outcome
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] %
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).
1 secondary outcome
Amount of Peptamen® and Beneprotein® consumed
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Resourcing issues impacted by COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Jeffrey Jiang Song'en, MBBS principal investigator
St. Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptamen® in people with Pressure Ulcer, run by St Luke's Hospital, Singapore at 1 site in Singapore.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Mar 2021. 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 Singapore. 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?
The study was stopped early (reason given: Resourcing issues impacted by COVID-19 pandemic.). Results are not available in the source record.
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?
Percentage Reduction in Wound Surface Area (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.