Diabetic Foot UlcerNCT04055064
The Effects of Nutrition Supplementation and Education on the Healing of Diabetic Foot Ulcer (DFU)
A study of Diabetic Foot Ulcer, run by Florida State University at 1 site in United States.
Trial summary
The overall aim of this study was to assess the effects of nutritional supplementation and education on the healing of foot ulcers in diabetic patients. The hypothesis was that improving dietary intake can promote wound healing by improving nutritional status, blood flow, and decreasing inflammatory biomarkers while… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 9 May 2018
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or non-pregnant, non-lactating female ages 50 ± 20 years, diagnosis of diabetes mellitus, undergoing pharmacological treatment for glycemic control, with at least one foot with one ulcer of grade 1A based on University of Texas classification -
Who cannot join
- Subjects were excluded from the study if they had HbA1c concentrations > 12%, bioengineered tissue use within four weeks prior to initial screening, a history of radiation treatment to the ulcer site, known immunosuppression, active malignancy, chronic kidney disease, liver failure/cirrhosis, heart failure and/or myocardial infarction in the past three months, use of warfarin, alcohol abuse, or any mental or physiological condition that may interfere with nutrition education and nutritional supplement intake.-
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Evaluating the Effects of Improving Nutritional Intake on Wound Healing in Patients With Diabetic Foot Ulcer
The overall aim of this study was to assess the effects of nutritional supplementation and education on the healing of foot ulcers in diabetic patients. The hypothesis was that improving dietary intake can promote wound healing by improving nutritional status, blood flow, and decreasing inflammatory biomarkers while increasing anti-inflammatory factors.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- glucose control nutritional shake, nutrition education
- Keywords
- DFU, wound healing, nutrition education,supplementation
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose control nutritional shake, nutrition educationDietary supplement
Also called Nutrition education
Participants in the treatment group were educated about improving their diet by consuming more low-fat high-quality protein sources, vegetables, complex carbohydrates and less simple carbohydrates. They were also instructed to consume two servings (474 ml) of a commercially produced Glucose Control Nutritional Shake between meals throughout the day for 12 weeks or until complete healing. The supplements provided a total of 500 kilocalories, 28 grams of high-quality protein and essential vitamins and minerals.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | patients received nutrition education and nutritional supplements Receives: Dietary Supplement: glucose control nutritional shake, nutrition education |
| Control | No intervention | patients did not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in wound healing rate(mm^2/week)
Mean change from baseline in wound area at weeks 4,8, and 12 using the following formula
Wound Healing rate= (current area-baseline area)/time (number of weeks)
Measured: 12 weeks
Change in inflammatory biomarkers
Mean change from baseline in c-reactive protein(ng/ml), interleukin 6(pg/ml), interleukin 10(pg/ml), and tristetraprolin(pg/ml) at weeks 4, 8, and 12
Measured: 12 weeks
Change in lean body mass and body fat
Mean change from baseline in lean body mass(lb) and body fat(lb) at weeks 4, 8, and 12
Measured: 12 weeks
Change in dietary intake of nutrients
Mean change from baseline in dietary intake of energy(kcal), protein(g), vitamin C(mg), vitamin E(IU), vitamin A(IU), Zinc(mg), Copper(mg), and Manganese(mg) at weeks 4, 8, and 12.
Measured: 12 weeks
Secondary outcomes (3)
Length of time that a wound achieves complete wound closure
Duration (number of days) to achieve complete wound closure from baseline assessed between both groups.
Measured: 12 weeks
Change in basal metabolic rate
Mean change from baseline in basal metabolic rate(kcal) at weeks 4, 8, and 12.
Measured: 12 weeks
Change in Ankle Brachial Index(ABI)
Mean change from baseline in ABI by comparing the blood pressure in the upper and lower limbs at weeks 4,8, and 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start23 May 2017
- Primary completion9 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raedeh Basiri, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055064
- Sponsor's protocol ID
- 2019.26726
- Other IDs
- 2019
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not able to share individual participant data due to IRB requirements
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Improving Nutritional Intake on Wound Healing in Patients With Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT04055064
- Acronym / sponsor ID
- 2019.26726
- Conditions
- Diabetic Foot Ulcer
- Keywords
- DFU, wound healing, nutrition education,supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 13 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.
The overall aim of this study was to assess the effects of nutritional supplementation and education on the healing of foot ulcers in diabetic patients. The hypothesis was that improving dietary intake can promote wound healing by improving nutritional status, blood flow, and decreasing inflammatory biomarkers while increasing anti-inflammatory factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: glucose control nutritional shake, nutrition educationpatients received nutrition education and nutritional supplements |
| Control | No intervention | –patients did not receive any intervention |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or non-pregnant, non-lactating female ages 50 ± 20 years, diagnosis of diabetes mellitus, undergoing pharmacological treatment for glycemic control, with at least one foot with one ulcer of grade 1A based on University of Texas classification -
Key exclusion criteria (1 listed)
- Subjects were excluded from the study if they had HbA1c concentrations > 12%, bioengineered tissue use within four weeks prior to initial screening, a history of radiation treatment to the ulcer site, known immunosuppression, active malignancy, chronic kidney disease, liver failure/cirrhosis, heart failure and/or myocardial infarction in the past three months, use of warfarin, alcohol abuse, or any mental or physiological condition that may interfere with nutrition education and nutritional supplement intake.-
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 |
|---|---|---|
| glucose control nutritional shake, nutrition educationAlso: Nutrition educationParticipants in the treatment group were educated about improving their diet by consuming more low-fat high-quality protein sources, vegetables, complex carbohydrates and less simple carbohydrates. They were also instructed to consume two servings (474 ml) of a commercially produced Glucose Control Nutritional Shake between meals throughout the day for 12 weeks or until complete healing. The supplements provided a total of 500 kilocalories, 28 grams of high-quality protein and essential vitamins and minerals. | Dietary supplement | Intervention |
Primary outcome
Improvement in wound healing rate(mm^2/week)
Time frame: 12 weeks
Mean change from baseline in wound area at weeks 4,8, and 12 using the following formula Wound Healing rate= (current area-baseline area)/time (number of weeks)
Change in inflammatory biomarkers
Time frame: 12 weeks
Mean change from baseline in c-reactive protein(ng/ml), interleukin 6(pg/ml), interleukin 10(pg/ml), and tristetraprolin(pg/ml) at weeks 4, 8, and 12
Change in lean body mass and body fat
Time frame: 12 weeks
Mean change from baseline in lean body mass(lb) and body fat(lb) at weeks 4, 8, and 12
Change in dietary intake of nutrients
Time frame: 12 weeks
Mean change from baseline in dietary intake of energy(kcal), protein(g), vitamin C(mg), vitamin E(IU), vitamin A(IU), Zinc(mg), Copper(mg), and Manganese(mg) at weeks 4, 8, and 12.
3 secondary outcomes
Length of time that a wound achieves complete wound closure
Time frame: 12 weeks
Change in basal metabolic rate
Time frame: 12 weeks
Change in Ankle Brachial Index(ABI)
Time frame: 12 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 13 Aug 2019.
- Individual participant dataSharing planned: No. not able to share individual participant data due to IRB requirements
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetic Foot Ulcer, run by Florida State University 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 1 inclusion and 1 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 13 Aug 2019. 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 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?
Improvement in wound healing rate(mm^2/week) (time frame: 12 weeks). The study lists 4 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 13 Aug 2019.