Pressure Ulcer ( Stage 2-3)NCT05461911
Study to Assess the Clinical Efficacy of the Specialized Enteral Tube Nutrition Composition Nutrison Advanced Cubison as a Part of Complex Pressure Ulcers (PU) Therapy
An observational study of Pressure Ulcer ( Stage 2-3), run by Enrollme.ru, LLC at 3 sites in Russia.
Trial summary
A large number of studies are devoted to studying the effect of patient nutrition on the occurrence and treatment of pressure ulcers. Several studies, including the US National Long-term Treatment of Pressure Ulcers Study, have shown that weight loss and malnutrition were associated with a higher risk of pressure… Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Pressure Ulcer ( Stage 2-3)
- What is being tested?
- Nutrison Advanced Cubison
- How many people
- 60 participants
- Where
- 3 sitesRussia
- Study dates
- 1 Jun 2021to 1 Dec 2021
- Phase
- Observational
- 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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 patients hospitalized with strokes or traumatic brain injury, who are on tube feeding and with the presence of pressure ulcers of 2-3 stages identified at baseline or during hospital stay
Who may be able to join
- Patients diagnosed with stroke / TBI and who are on tube feeding
- Presence of pressure ulcers of 2-3 stages
- Informed voluntary consent to medical intervention is formalized in accordance with the requirements of the Federal Law of 21.11.2011 N 323-FZ "On the basics of protecting the health of citizens in the Russian Federation."
- Uncertainty of the investigator about the willingness or ability of the subject to comply with the protocol requirements
- Any other medical or non-medical reasons that, in the opinion of the physician, may prevent the patient from participating in the study
Who cannot join
- Hemodynamically unstable patients
- Severe renal impairment (GFR <30 ml / min)
- Moderate or severe liver failure (Child-Pugh Class B or C)
- Oncological diseases (lasting more than 5 years)
- Hypersensitivity to any component of the test food mixture
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
GAUZ Bryansk city hospital №1
Bryansk
GBUZ GKB named after VV Vinogradov DZM
Moscow
Hospital named after V.D. Seredavin
Samara
About this study
Official title: Prospective Multicenter Randomized Controlled Low-interventional Post-registration Study to Assess the Clinical Efficacy of the Specialized Enteral Tube Nutrition Composition Nutrison Advanced Cubison as a Part of Complex Pressure Ulcers (PU) Therapy Versus Standard Enteral Tube Nutrition Products
A large number of studies are devoted to studying the effect of patient nutrition on the occurrence and treatment of pressure ulcers. Several studies, including the US National Long-term Treatment of Pressure Ulcers Study, have shown that weight loss and malnutrition were associated with a higher risk of pressure ulcers.
One of the successful products specially created for the treatment of pressure ulcers and taking into account the results of research is the high-protein, energy-rich, ready-to-use enteral tube feeding food product Nutrison Advanced Cubison. It is a complete enteral nutritional supplement with an innovative nutrient composition for patients with chronic wounds, including pressure ulcers, or at increased risk of developing them.
Taking into account the available data, it seems expedient to continue studying the unique combination of nutrients that make up the study food product Nutrison Advanced Cubison in order to develop the most effective nutritional protocols for patients at risk for the treatment and prevention of pressure ulcers.
- Conditions
- Pressure Ulcer ( Stage 2-3)
- Being tested
- Nutrison Advanced Cubison
- Keywords
- Stroke, Traumatic Brain Injury
- Medical subject headings
- Pressure Ulcer, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrison Advanced CubisonDietary supplement
(20% protein energy 100 kcal, 5.5 g protein, 0.85 g arginine, 38 mg of vitamin C and 2 mg of zinc) in a volume not exceeding 1.5 liters / day and, if necessary, to replenish nutritional needs based on the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g of protein / kg body weight / day according to the recommendations for nutritional support
| Study group | Role | What they receive |
|---|---|---|
| The Study Group | 30 adult patients aged 30-75 years to receive a specialized tube feeding product Nutrison Advanced Cubison (20% protein energy 100 kcal, 5.5 g protein, 0.85 g arginine, 38 mg of vitamin C and 2 mg of zinc) in a volume not exceeding 1.5 liters / day and, if necessary, to replenish nutritional needs based on the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g of protein / kg body weight / day according to the recommendations for nutritional support for patients with pressure ulcers during the entire observation period Receives: Dietary Supplement: Nutrison Advanced Cubison | |
| The Control Group | 30 patients aged 30-75 years to receive a standard (available in the clinic) tube feeding product (energetically similar to the product in group 1) with a standard content of arginine, vitamins and minerals from calculating the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g protein / kg body weight / day according to the recommendations for nutritional support for patients with pressure ulcers during the entire observation period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the area of pressure ulcers in both groups during the study
Measured: up to 4 weeks
The proportion of patients in both groups with a decrease in the area of the pressure ulcer by 20% or more by the date of completion of observations
Measured: up to 4 weeks
Changes in the Pressure Ulcer Scale for Healing values in both groups during the study
Pressure Ulcer Scale for Healing (PUSH) is a common tool to monitor pressure healing over time. The PUSH Tool monitors three parameters: surface area of the wound, wound exudate and type of wound tissue. Minimum value is 0, maximum value is 17. The bigger scale is the worse
Measured: up to 4 weeks
Secondary outcomes (5)
Duration of treatment for pressure ulcers in study patients
Measured: up to 4 weeks
Frequency and duration of infectious complications of pressure ulcers in study patients
Measured: up to 4 weeks
Concentration of the blood albumin at the beginning and at the end of observations
Measured: up to 4 weeks
Concentration of the blood lymphocytes at the beginning and at the end of observations
Measured: up to 4 weeks
Concentration of the C-reactive protein at the beginning and at the end of observations
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Jun 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer ( Stage 2-3)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrollme.ru, LLC
- Sponsor type
- Research network
- Collaborators
- Danone Nutricia
- Responsible party
- Sponsor
- Investigators
- Mikhail Getman, Dr, Study director, Enrollme.ru, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461911
- Sponsor's protocol ID
- DECUBISON
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Randomized Controlled Low-interventional Post-registration Study to Assess the Clinical Efficacy of the Specialized Enteral Tube Nutrition Composition Nutrison Advanced Cubison as a Part of Complex Pressure Ulcers (PU) Therapy Versus Standard Enteral Tube Nutrition Products
- ClinicalTrials.gov ID
- NCT05461911
- Acronym / sponsor ID
- DECUBISON
- Conditions
- Pressure Ulcer ( Stage 2-3)
- Keywords
- Stroke, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Enrollme.ru, LLCResearch network
- Collaborators
- Danone Nutricia
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 Jul 2022 (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.
A large number of studies are devoted to studying the effect of patient nutrition on the occurrence and treatment of pressure ulcers. Several studies, including the US National Long-term Treatment of Pressure Ulcers Study, have shown that weight loss and malnutrition were associated with a higher risk of pressure ulcers.
One of the successful products specially created for the treatment of pressure ulcers and taking into account the results of research is the high-protein, energy-rich, ready-to-use enteral tube feeding food product Nutrison Advanced Cubison. It is a complete enteral nutritional supplement with an innovative nutrient composition for patients with chronic wounds, including pressure ulcers, or at increased risk of developing them.
Taking into account the available data, it seems expedient to continue studying the unique combination of nutrients that make up the study food product Nutrison Advanced Cubison in order to develop the most effective nutritional protocols for patients at risk for the treatment and prevention of pressure ulcers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Study Group | – | Dietary Supplement: Nutrison Advanced Cubison30 adult patients aged 30-75 years to receive a specialized tube feeding product Nutrison Advanced Cubison (20% protein energy 100 kcal, 5.5 g protein, 0.85 g arginine, 38 mg of vitamin C and 2 mg of zinc) in a volume not exceeding 1.5 liters / day and, if necessary, to replenish nutritional needs based on the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g of protein / kg body weight / day according to the recommendations for nutritional support for patients with pressure ulcers during the entire observation period |
| The Control Group | – | –30 patients aged 30-75 years to receive a standard (available in the clinic) tube feeding product (energetically similar to the product in group 1) with a standard content of arginine, vitamins and minerals from calculating the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g protein / kg body weight / day according to the recommendations for nutritional support for patients with pressure ulcers during the entire observation period |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients hospitalized with strokes or traumatic brain injury, who are on tube feeding and with the presence of pressure ulcers of 2-3 stages identified at baseline or during hospital stay
Key inclusion criteria (5 listed)
- Patients diagnosed with stroke / TBI and who are on tube feeding
- Presence of pressure ulcers of 2-3 stages
- Informed voluntary consent to medical intervention is formalized in accordance with the requirements of the Federal Law of 21.11.2011 N 323-FZ "On the basics of protecting the health of citizens in the Russian Federation."
- Uncertainty of the investigator about the willingness or ability of the subject to comply with the protocol requirements
- Any other medical or non-medical reasons that, in the opinion of the physician, may prevent the patient from participating in the study
Key exclusion criteria (5 listed)
- Hemodynamically unstable patients
- Severe renal impairment (GFR <30 ml / min)
- Moderate or severe liver failure (Child-Pugh Class B or C)
- Oncological diseases (lasting more than 5 years)
- Hypersensitivity to any component of the test food mixture
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 |
|---|---|---|
| Nutrison Advanced Cubison(20% protein energy 100 kcal, 5.5 g protein, 0.85 g arginine, 38 mg of vitamin C and 2 mg of zinc) in a volume not exceeding 1.5 liters / day and, if necessary, to replenish nutritional needs based on the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g of protein / kg body weight / day according to the recommendations for nutritional support | Dietary supplement | The Study Group |
Primary outcome
Changes in the area of pressure ulcers in both groups during the study
Time frame: up to 4 weeks
The proportion of patients in both groups with a decrease in the area of the pressure ulcer by 20% or more by the date of completion of observations
Time frame: up to 4 weeks
Changes in the Pressure Ulcer Scale for Healing values in both groups during the study
Time frame: up to 4 weeks
Pressure Ulcer Scale for Healing (PUSH) is a common tool to monitor pressure healing over time. The PUSH Tool monitors three parameters: surface area of the wound, wound exudate and type of wound tissue. Minimum value is 0, maximum value is 17. The bigger scale is the worse
5 secondary outcomes
Duration of treatment for pressure ulcers in study patients
Time frame: up to 4 weeks
Frequency and duration of infectious complications of pressure ulcers in study patients
Time frame: up to 4 weeks
Concentration of the blood albumin at the beginning and at the end of observations
Time frame: up to 4 weeks
Concentration of the blood lymphocytes at the beginning and at the end of observations
Time frame: up to 4 weeks
Concentration of the C-reactive protein at the beginning and at the end of observations
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Pressure Ulcer ( Stage 2-3)
Not yet recruitingEarly Phase 1
Efficacy of a Polyhexanide Biguanide-Based Gel in the Prevention of Biofilm Formation in Pressure Ulcers
Pressure Ulcers, Pressure Ulcers Stage III
Recruiting
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Pressure Ulcers Stage II, Pressure Ulcers Stage III
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.
Mikhail Getman, Dr study director
Enrollme.ru, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer ( Stage 2-3), run by Enrollme.ru, LLC at 3 sites in Russia.
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 5 inclusion and 5 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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 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?
Changes in the area of pressure ulcers in both groups during the study (time frame: up to 4 weeks). The study lists 3 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 18 Jul 2022.