Pressure UlcersPhase 1NCT00502372
Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)
A Phase 1 study testing Nutritional Supplement/Amino acids and HMB and Juven in people with Pressure Ulcers, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
Trial summary
The focus of this study is to look at the role of nutrition in the healing of pressure ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, B-hydroxy-B-methylbutyrate is… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Nutritional Supplement/Amino acids and HMB and Juven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 1
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Stage II pressure ulcer or greater
- Patients who consent to participate
- Patients who can ingest the supplement either orally or per feeding tube
- Patients who are 21 years of age or older
Who cannot join
- Patients with infected wounds
- Patients with cellulitis, sepsis or osteomyelitis
- Patients with end-organ failure
- Patients with poorly controlled diabetes mellitus (HbA1C>10)
- Patients who cannot tolerate oral or bolus tube feedings
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205
About this study
Official title: Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate
The focus of this study is to look at the role of nutrition in the healing of pressure ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients receiving a supplement containing only one of the proteins in the experimental supplement
Read the detailed description
Patients who have pressure ulcers Stage II or greater will be randomized to receiving one of two nutritional supplements. One supplement contains arginine and the other contains both arginine,glutamine and leucine metabolites. Pressure ulcers will be measured at study entry and measured biweekly using a standardized tool (PUSH) until the trial is completed or the pressure ulcer has healed.
Inclusion criteria include:
- Stage II or greater pressure ulcer
- Patient consent
- Patients who can drink supplement or receive it by tube
- Patients who are 21 years old or greater
Exclusion criteria include:
- Patients with infected wounds
- Patients with cellulitis, sepsis or osteomyelitis
- Patients with end-organ failure
- Patients with poorly controlled diabetes mellitus (HbA1C>10)
- Patients who cannot tolerate oral or tube feeding
- Conditions
- Pressure Ulcers
- Being tested
- Nutritional Supplement/Amino acids and HMB, Juven
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Supplement/Amino acids and HMBDietary supplement
Also called Juven, Argenaid
Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement
JuvenDietary supplement
Also called Argenaid
comparison of Juven with arginine only product in wound healing
| Study group | Role | What they receive |
|---|---|---|
| Enriched product, dietary supplement | Experimental | Subjects receiving enriched product compared to an unenriched product Receives: Dietary Supplement: Nutritional Supplement/Amino acids and HMB; Dietary Supplement: Juven |
| 1 | Active comparator | Subjects not receiving enriched product Receives: Dietary Supplement: Nutritional Supplement/Amino acids and HMB; Dietary Supplement: Juven |
What is being measured
The primary outcome is the main question the study is designed to answer.
PUSH tool score
The PUSH tool measures the healing of a pressure ulcer by actually measuring the depth and width, in 2 dimensions, of a wound. A wound heals from the wound bed and closes from the inside to the outside if healthy pink granulation tissue can be seen. This tool contributes to the consistency of measurement of a healing wound.
Measured: 8 weeks or healing completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: VA never granted approval following suspension of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Arkansas Veterans Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Cathey Powers, MD, Principal investigator, Central Arkansas VA/UAMS College of MedicineRonni Chernoff, PhD, Principal investigator, Central Arkansas VA/UAMS College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502372
- Sponsor's protocol ID
- BJ93
- Status last verified
- Dec 2015
- First submitted
- 13 Jul 2007
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate
- ClinicalTrials.gov ID
- NCT00502372
- Acronym / sponsor ID
- BJ93
- Conditions
- Pressure Ulcers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: VA never granted approval following suspension of enrollment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Central Arkansas Veterans Healthcare SystemUS federal agency
- Collaborators
- Abbott
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Jul 2007 (estimated)
- 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.
The focus of this study is to look at the role of nutrition in the healing of pressure ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients receiving a supplement containing only one of the proteins in the experimental supplement
Detailed description
Patients who have pressure ulcers Stage II or greater will be randomized to receiving one of two nutritional supplements. One supplement contains arginine and the other contains both arginine,glutamine and leucine metabolites. Pressure ulcers will be measured at study entry and measured biweekly using a standardized tool (PUSH) until the trial is completed or the pressure ulcer has healed.
Inclusion criteria include:
- Stage II or greater pressure ulcer
- Patient consent
- Patients who can drink supplement or receive it by tube
- Patients who are 21 years old or greater
Exclusion criteria include:
- Patients with infected wounds
- Patients with cellulitis, sepsis or osteomyelitis
- Patients with end-organ failure
- Patients with poorly controlled diabetes mellitus (HbA1C>10)
- Patients who cannot tolerate oral or tube feeding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enriched product, dietary supplement | Experimental | Dietary Supplement: Nutritional Supplement/Amino acids and HMB, Dietary Supplement: JuvenSubjects receiving enriched product compared to an unenriched product |
| 1 | Active comparator | Dietary Supplement: Nutritional Supplement/Amino acids and HMB, Dietary Supplement: JuvenSubjects not receiving enriched product |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Stage II pressure ulcer or greater
- Patients who consent to participate
- Patients who can ingest the supplement either orally or per feeding tube
- Patients who are 21 years of age or older
Key exclusion criteria (5 listed)
- Patients with infected wounds
- Patients with cellulitis, sepsis or osteomyelitis
- Patients with end-organ failure
- Patients with poorly controlled diabetes mellitus (HbA1C>10)
- Patients who cannot tolerate oral or bolus tube feedings
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 |
|---|---|---|
| Nutritional Supplement/Amino acids and HMBAlso: Juven, ArgenaidSubjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement | Dietary supplement | 1, Enriched product, dietary supplement |
| JuvenAlso: Argenaidcomparison of Juven with arginine only product in wound healing | Dietary supplement | 1, Enriched product, dietary supplement |
Primary outcome
PUSH tool score
Time frame: 8 weeks or healing completed
The PUSH tool measures the healing of a pressure ulcer by actually measuring the depth and width, in 2 dimensions, of a wound. A wound heals from the wound bed and closes from the inside to the outside if healthy pink granulation tissue can be seen. This tool contributes to the consistency of measurement of a healing wound.
Results and safety
The study was stopped early (reason given: VA never granted approval following suspension of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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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.
Cathey Powers, MD principal investigator
Central Arkansas VA/UAMS College of Medicine
Ronni Chernoff, PhD principal investigator
Central Arkansas VA/UAMS College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nutritional Supplement/Amino acids and HMB and Juven in people with Pressure Ulcers, run by Central Arkansas Veterans Healthcare System 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 4 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: stopped early, as of the sponsor's last update on 15 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: VA never granted approval following suspension of 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?
PUSH tool score (time frame: 8 weeks or healing completed). 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 15 Dec 2015.