Diabetic FootNCT03679273
Nutritional Supplement on Wound Healing in Diabetic Foot
A study testing Abound in people with Diabetic Foot, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Diabetic foot ulcer (DFU) is the leading cause of non-traumatic limb loss in adult worldwide. One of the major causes of limb loss in patients with DFU is poor wound healing. It is known that nutrition plays a key role in wound healing, not only because of the required calories, but more importantly for collagen… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Abound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 15 May 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be considered for entry if they are men or non-pregnant women, aged ≥ 40 years or ≤ 80 years
- a serum albumin level between 2.0 mg/dL and 4.0 mg/dL, had peripheral occlusive arterial disease with an ankle-brachial index (ABI) ≤0.9 or Doppler arterial waveforms that are biphasic or monophasic
- a serum C-reactive protein level ≤ 50 mg/L .
Who cannot join
- Subjects will be excluded from the study if they have serious comorbidities such as
- pneumonia,
- active malignancy, severe renal function impairment (creatinine < 3 mg/dl), heart failure (NYHA Fc ≥ 3),
- liver failure/cirrhosis (Child class B or C),
- myocardial infarction in the past 3 months,
- wounds complicated with persistent osteomyelitis,
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- a Charcot deformity,
- alcohol/substance abuse,
- any mental or physiological condition that may interfere with dietary intake,
- history of allergy to any of the ingredients in the supplement,
- those who are unable to follow orders or cooperate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei, 333
Yu-Yao Huang, +88633281200 ext. 8826, yyh@gmail.com
About this study
Official title: Clinical Effectiveness and Molecular Mechanisms of Nutritional Supplement on Wound Healing in Diabetic Patients With Limb-threatening Foot Ulcer
Diabetic foot ulcer (DFU) is the leading cause of non-traumatic limb loss in adult worldwide. One of the major causes of limb loss in patients with DFU is poor wound healing. It is known that nutrition plays a key role in wound healing, not only because of the required calories, but more importantly for collagen remodeling by specific amino acids (arginine, glutamine, and β-hydroxy-β-methylbutyrate).
Nevertheless, few studies have investigated nutritional supplements in patients with poor wound healing of DFU. Difficulties in assessing the severity of a wound and poor adherence to drug and food supplements at home may be important factors for the negative results shown in a most recent prospective randomized controlled trial. The diabetic foot center in Chang Gung Memorial hospital has extensive experience in caring for patients with limb-threatening DFU and we recently reported that poor nutritional status in our patients correlated to poor treatment outcomes. The aim of this study is to evaluate the clinical efficacy and possible molecular mechanisms in nutritional treatment for limb-threatening DFU. A total of 70 patients will be enrolled and randomized into study and control groups. All subjects will receive standard care. Additional amino acid supplements containing arginine, glutamine, and β-hydroxy-β-methylbutyrate or a control (high protein formula powder) will be given orally twice a day for 21 days, and the percentage change in wound size will then be measured. Complete healing time, recurrence or major adverse cardiac events will be recorded during one year of follow up. Data on wound size, nutritional status, and levels of matrix metallopeptidase (MMP)-2, MMP-9, nutrient molecules (measured by ABSOLUTE/DQ P180 KIT (LC MS/MS) will be recorded before and after the nutritional supplementation. In addition, the pioneer factor forkhead box protein A2 (FOXA2) that binds native chromatin and bookmarks genomic regions for transcriptional activity may play a role in nutritional supplements in acute stressed diabetic patients. Therefore, we intend to conduct a pilot study on the for FOXA2 gene in maintaining glucose homeostasis in diabetic foot patients after nutritional interventions.
- Conditions
- Diabetic Foot
- Being tested
- Abound
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AboundDietary supplement
Study Group will take the supplementation drink containing 79 kcal, 7 g L-arginine, 7 g L-glutamine and 1.5 g calcium β-hydroxy-β-methylbutyrate (Abound; Abbott Nutrition, Columbus, OH, USA). The subjects will be instructed to drink the entire packet dissolved in 250 ml of water twice per day for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Abound supplement | Experimental | The participant will take the supplementation drink containing 79 kcal, 7 g L-arginine, 7 g L-glutamine and 1.5 g calcium β-hydroxy-β-methylbutyrate (Abound; Abbott Nutrition, Columbus, OH, USA). The subjects will be instructed to drink the entire packet dissolved in 250 ml of water twice per day for 21 days. Receives: Dietary Supplement: Abound |
| Traditional supplement | No intervention | The participant will take traditional diabetes-specific formula as provided by dietitians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEDIS score
Measurement of wound size change
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion15 May 2020 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679273
- Sponsor's protocol ID
- 104-9965A3
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 20 Sep 2018
- 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 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Molecular Mechanisms of Nutritional Supplement on Wound Healing in Diabetic Patients With Limb-threatening Foot Ulcer
- ClinicalTrials.gov ID
- NCT03679273
- Acronym / sponsor ID
- 104-9965A3
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 20 Sep 2018 (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.
Diabetic foot ulcer (DFU) is the leading cause of non-traumatic limb loss in adult worldwide. One of the major causes of limb loss in patients with DFU is poor wound healing. It is known that nutrition plays a key role in wound healing, not only because of the required calories, but more importantly for collagen remodeling by specific amino acids (arginine, glutamine, and β-hydroxy-β-methylbutyrate).
Nevertheless, few studies have investigated nutritional supplements in patients with poor wound healing of DFU. Difficulties in assessing the severity of a wound and poor adherence to drug and food supplements at home may be important factors for the negative results shown in a most recent prospective randomized controlled trial. The diabetic foot center in Chang Gung Memorial hospital has extensive experience in caring for patients with limb-threatening DFU and we recently reported that poor nutritional status in our patients correlated to poor treatment outcomes. The aim of this study is to evaluate the clinical efficacy and possible molecular mechanisms in nutritional treatment for limb-threatening DFU. A total of 70 patients will be enrolled and randomized into study and control groups. All subjects will receive standard care. Additional amino acid supplements containing arginine, glutamine, and β-hydroxy-β-methylbutyrate or a control (high protein formula powder) will be given orally twice a day for 21 days, and the percentage change in wound size will then be measured. Complete healing time, recurrence or major adverse cardiac events will be recorded during one year of follow up. Data on wound size, nutritional status, and levels of matrix metallopeptidase (MMP)-2, MMP-9, nutrient molecules (measured by ABSOLUTE/DQ P180 KIT (LC MS/MS) will be recorded before and after the nutritional supplementation. In addition, the pioneer factor forkhead box protein A2 (FOXA2) that binds native chromatin and bookmarks genomic regions for transcriptional activity may play a role in nutritional supplements in acute stressed diabetic patients. Therefore, we intend to conduct a pilot study on the for FOXA2 gene in maintaining glucose homeostasis in diabetic foot patients after nutritional interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abound supplement | Experimental | Dietary Supplement: AboundThe participant will take the supplementation drink containing 79 kcal, 7 g L-arginine, 7 g L-glutamine and 1.5 g calcium β-hydroxy-β-methylbutyrate (Abound; Abbott Nutrition, Columbus, OH, USA). The subjects will be instructed to drink the entire packet dissolved in 250 ml of water twice per day for 21 days. |
| Traditional supplement | No intervention | –The participant will take traditional diabetes-specific formula as provided by dietitians. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be considered for entry if they are men or non-pregnant women, aged ≥ 40 years or ≤ 80 years
- a serum albumin level between 2.0 mg/dL and 4.0 mg/dL, had peripheral occlusive arterial disease with an ankle-brachial index (ABI) ≤0.9 or Doppler arterial waveforms that are biphasic or monophasic
- a serum C-reactive protein level ≤ 50 mg/L .
Key exclusion criteria (11 listed)
- Subjects will be excluded from the study if they have serious comorbidities such as
- pneumonia,
- active malignancy, severe renal function impairment (creatinine < 3 mg/dl), heart failure (NYHA Fc ≥ 3),
- liver failure/cirrhosis (Child class B or C),
- myocardial infarction in the past 3 months,
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 |
|---|---|---|
| AboundStudy Group will take the supplementation drink containing 79 kcal, 7 g L-arginine, 7 g L-glutamine and 1.5 g calcium β-hydroxy-β-methylbutyrate (Abound; Abbott Nutrition, Columbus, OH, USA). The subjects will be instructed to drink the entire packet dissolved in 250 ml of water twice per day for 21 days. | Dietary supplement | Abound supplement |
Primary outcome
PEDIS score
Time frame: one year
Measurement of wound size change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Better Care Closer to Home: Enhancing Primary and Community Care
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EDX110 Randomized Control Trial for Treatment of DFUs
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abound in people with Diabetic Foot, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Sep 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Yao Huang, MD, PhD (+886-3-3281200 ext. 8826, yyh@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEDIS score (time frame: one year). 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 20 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.