Compliance, PatientNCT04041908
Use of a Medical Food in Adults Undergoing Surgery
A study testing Experimental Product in people with Compliance, Patient, run by Abbott Nutrition at 1 site in United States.
Trial summary
Multi-center, prospective, one arm study to evaluate the addition of a medical food to the standard of care in elderly adults undergoing a surgical procedure. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Compliance, Patient
- What is being tested?
- Experimental Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2020to 10 Apr 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is scheduled to have non-melanoma skin cancer on either the head, leg, trunk and arm removed with final wound size of 1.0 to < 5.0 cm in diameter or with 1.0 < 5.0 cm long axis if not circular that will be healed by secondary intent
- Participant has an acceptable state of health and nutrition
- Participant agrees not to begin taking any new medications, dietary supplements, or alternative therapies during the study period
- Participant is interested in participating in the study, willing to comply with the study protocol, and willing to consume two servings of drink mix per day according to the protocol
- Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability (HIPAA) authorization prior to any study participation
Who cannot join
- Participant has a disease or condition that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the participant with study visits/procedures
- Participant has type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Participant has known immunosuppression
- Participant has platelet or coagulation disorders
- Therapy with another investigational agent within 30 days of Visit 1 that has not been approved
- Systemic infection at the time of enrollment in the study
Show all 10Show fewer
- Currently receiving or have received recombinant human platelet-derived growth factor or similar therapies, or other bioengineered tissue therapy within the previous 4 weeks
- Participant has an allergy or intolerance to any ingredient in the study product
- Participant is taking nutritional supplement(s)/capsules/formulas for wound healing and is unwilling to discontinue therapy for the duration of the study
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observation of the Use of a Medical Food in Older Adults Undergoing Surgery
Multi-center, prospective, one arm study to evaluate the addition of a medical food to the standard of care in elderly adults undergoing a surgical procedure.
- Conditions
- Compliance, Patient
- Being tested
- Experimental Product
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ProductOther
2 sachets per day
| Study group | Role | What they receive |
|---|---|---|
| Experimental Product | Experimental | Drink mix powder Receives: Other: Experimental Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Compliance
Percent of required study product intake from subject completed intake questionnaire
Measured: Study Day 1 to Study Day 30
Secondary outcomes (2)
Investigator Wound Assessment
Percent of patients with complete wound healing based on physician assessment
Measured: Study Day 1 to Study Day 30
Participant Wound Assessment Questionnaire
Participant completed 4 questions related to wound healing experience; 3 Likert-type questions scaled from 1-10 in negative direction; 1 dichotomous scale question
Measured: Study Day 14 and Study Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start13 Mar 2020
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance, PatientStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Nelson, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041908
- Sponsor's protocol ID
- BL42
- Status last verified
- Apr 2020
- First submitted
- 30 Jul 2019
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Use of a Medical Food in Older Adults Undergoing Surgery
- ClinicalTrials.gov ID
- NCT04041908
- Acronym / sponsor ID
- BL42
- Conditions
- Compliance, Patient
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 1 Aug 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.
Multi-center, prospective, one arm study to evaluate the addition of a medical food to the standard of care in elderly adults undergoing a surgical procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Product | Experimental | Other: Experimental ProductDrink mix powder |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is scheduled to have non-melanoma skin cancer on either the head, leg, trunk and arm removed with final wound size of 1.0 to < 5.0 cm in diameter or with 1.0 < 5.0 cm long axis if not circular that will be healed by secondary intent
- Participant has an acceptable state of health and nutrition
- Participant agrees not to begin taking any new medications, dietary supplements, or alternative therapies during the study period
- Participant is interested in participating in the study, willing to comply with the study protocol, and willing to consume two servings of drink mix per day according to the protocol
- Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability (HIPAA) authorization prior to any study participation
Key exclusion criteria (10 listed)
- Participant has a disease or condition that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the participant with study visits/procedures
- Participant has type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- Participant has known immunosuppression
- Participant has platelet or coagulation disorders
- Therapy with another investigational agent within 30 days of Visit 1 that has not been approved
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 |
|---|---|---|
| Experimental Product2 sachets per day | Other | Experimental Product |
Primary outcome
Product Compliance
Time frame: Study Day 1 to Study Day 30
Percent of required study product intake from subject completed intake questionnaire
2 secondary outcomes
Investigator Wound Assessment
Time frame: Study Day 1 to Study Day 30
Participant Wound Assessment Questionnaire
Time frame: Study Day 14 and Study Day 30
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
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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 Nelson, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Product in people with Compliance, Patient, run by Abbott Nutrition at 1 site in United States.
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 10 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 1 May 2020. 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 United States. 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: Low enrollment). 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?
Product Compliance (time frame: Study Day 1 to Study Day 30). 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 1 May 2020.