The Effects of Nutrition Supplementation and Education on the Healing of Diabetic Foot Ulcer (DFU)
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|ClinicalTrials.gov Identifier: NCT04055064|
Recruitment Status : Completed
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Dietary Supplement: glucose control nutritional shake, nutrition education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Effects of Improving Nutritional Intake on Wound Healing in Patients With Diabetic Foot Ulcer|
|Actual Study Start Date :||May 23, 2017|
|Actual Primary Completion Date :||May 9, 2018|
|Actual Study Completion Date :||May 9, 2018|
patients received nutrition education and nutritional supplements
Dietary Supplement: glucose control nutritional shake, 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.
Other Name: Nutrition education
No Intervention: Control
patients did not receive any intervention
- 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.
- Length of time that a wound achieves complete wound closure [ Time Frame: 12 weeks ]Duration (number of days) to achieve complete wound closure from baseline assessed between both groups.
- Change in basal metabolic rate [ Time Frame: 12 weeks ]Mean change from baseline in basal metabolic rate(kcal) at weeks 4, 8, and 12.
- Change in Ankle Brachial Index(ABI) [ Time Frame: 12 weeks ]Mean change from baseline in ABI by comparing the blood pressure in the upper and lower limbs at weeks 4,8, and 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055064
|United States, Florida|
|Florida State University|
|Tallahassee, Florida, United States, 32306|