Healing UlcerNCT05464407
High Protein Oral Nutritional Support With Special Nutrients in Patients With Type 2 Diabetes and Foot Ulcer
A study testing Cubitan in people with Healing Ulcer, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
To assess the supplement of a high protein oral nutritional supplement enriched with arginin, zink, vitamin c and antioxidants on the healing of foot ulcers in patients with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Healing Ulcer
- What is being tested?
- Cubitan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Feb 2022to 31 Mar 2023
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes with newly diagnosed foot ulcer
- accept study participation
Who cannot join
- HbA1c >90 mmol/L
- cognitive challenges, fx dementia
- history with known alcohol or drug abuse
- allergy to milk or soya
- home less
- critical ischemia, distal blood pressure <0.30
- EGFR < 30
- dialysis or planned dialysis or patients with terminal kidney insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effekt af højproteindrik Med særligt Udvalgte næringsstoffer Til Mennesker Med Type 2 Diabetes og fodsår
To assess the supplement of a high protein oral nutritional supplement enriched with arginin, zink, vitamin c and antioxidants on the healing of foot ulcers in patients with type 2 diabetes mellitus
Read the detailed description
The intervention group receive 2 x ONS drink daily (total 2 x 200 kcal, 3 g arginin, 250 ml vitamin C, 38 mg vitamin e, 64 micr.g selenium, 9 mg zink)
- Conditions
- Healing Ulcer
- Being tested
- Cubitan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CubitanDietary supplement
2 bottles of Cubitan daily, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cubitan | Experimental | 2 x oral nutritional supplement daily Receives: Dietary Supplement: Cubitan |
| Usual care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
foot ulcer area
Reduction in ulcer area of the index ulcer, cm^2(based on height and width) within 12 weeks
Measured: 12 weeks
Foot ulcer healing
Time to complete healing
Measured: 12 weeks
Secondary outcomes (12)
Compliance to intervention
number of bottles ingested/bottles expected to ingest
Measured: 12 weeks
Accept of intervention
Measured by Visual Analogue Scale, minimum score 1, maximum score 5. Lower score is better outcome
Measured: 12 weeks
HbA1c
Change in HbA1c
Measured: 12 weeks and 6 months
Adverse events
number of adverse events in relation to hypo- or hyperglycemia, amputations, kidney function
Measured: 12 weeks and 6 months
Body weight
change in body weight
Measured: 12 weeks and 6 months
Improvement in Quality of life
World Health Organisation - Five Well-Being Index (WHO 5). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: 12 weeks and 6 months
Number of foot ulcers
number of foot ulcers
Measured: 12 weeks and 6 months
Depth foot ulcer
Reduction in depth within 12 weeks
Measured: 12 weeks
Classifying/scoring of food ulcer
Use of SINBAD (site-ischemia-neuropathy-bacterial infection-area-depth) score system. Minimum score 0, maximum score 6. Lower score is better outcome
Measured: 12 weeks and 6 months
Time to complete healing of foot ulcer
Time to complete healing of foot ulcer
Time to complete heling of foot ulcer
Measured: 6 months
Reduction in ulcer area
Reduction in ulcer area of the index ulcer, cm^2 (based on height and width)
Measured: 6 months
Number of new foot ulcers
Counting the number of new foot ulcers occuring after study inclusion
Measured: 12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start24 Feb 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Why it stopped: Slow patient reqruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing UlcerStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randi Tobberup, Aalborg University Hospital
- Investigators
- Randi Tobberup, phd, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464407
- Sponsor's protocol ID
- N20210057
- Status last verified
- Jan 2024
- First submitted
- 22 Apr 2022
- Last updated
- 31 Jan 2024
- Results posted
- 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekt af højproteindrik Med særligt Udvalgte næringsstoffer Til Mennesker Med Type 2 Diabetes og fodsår
- ClinicalTrials.gov ID
- NCT05464407
- Acronym / sponsor ID
- N20210057
- Conditions
- Healing Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow patient reqruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 19 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.
To assess the supplement of a high protein oral nutritional supplement enriched with arginin, zink, vitamin c and antioxidants on the healing of foot ulcers in patients with type 2 diabetes mellitus
Detailed description
The intervention group receive 2 x ONS drink daily (total 2 x 200 kcal, 3 g arginin, 250 ml vitamin C, 38 mg vitamin e, 64 micr.g selenium, 9 mg zink)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cubitan | Experimental | Dietary Supplement: Cubitan2 x oral nutritional supplement daily |
| Usual care | No intervention | –usual care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes with newly diagnosed foot ulcer
- accept study participation
Key exclusion criteria (8 listed)
- HbA1c >90 mmol/L
- cognitive challenges, fx dementia
- history with known alcohol or drug abuse
- allergy to milk or soya
- home less
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 |
|---|---|---|
| Cubitan2 bottles of Cubitan daily, for 12 weeks. | Dietary supplement | Cubitan |
Primary outcome
foot ulcer area
Time frame: 12 weeks
Reduction in ulcer area of the index ulcer, cm^2(based on height and width) within 12 weeks
Foot ulcer healing
Time frame: 12 weeks
Time to complete healing
12 secondary outcomes
Compliance to intervention
Time frame: 12 weeks
Accept of intervention
Time frame: 12 weeks
HbA1c
Time frame: 12 weeks and 6 months
Adverse events
Time frame: 12 weeks and 6 months
Body weight
Time frame: 12 weeks and 6 months
Improvement in Quality of life
Time frame: 12 weeks and 6 months
Number of foot ulcers
Time frame: 12 weeks and 6 months
Depth foot ulcer
Time frame: 12 weeks
Classifying/scoring of food ulcer
Time frame: 12 weeks and 6 months
Time to complete healing of foot ulcer
Time frame: 6 months
Reduction in ulcer area
Time frame: 6 months
Number of new foot ulcers
Time frame: 12 weeks and 6 months
Results and safety
The study was stopped early (reason given: Slow patient reqruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- 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.
Randi Tobberup, phd principal investigator
Aalborg University 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 Cubitan in people with Healing Ulcer, run by Aalborg University Hospital at 1 site in Denmark.
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 2 inclusion and 8 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 31 Jan 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 Denmark. 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: Slow patient reqruitment). 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?
foot ulcer area (time frame: 12 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 31 Jan 2024.