The Effects of Nutrition Supplementation and Education on the Healing of Diabetic Foot Ulcer (DFU)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Effects of Improving Nutritional Intake on Wound Healing in Patients With Diabetic Foot Ulcer

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Dietary Supplement: glucose control nutritional shake, nutrition education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 - Exclusion Criteria: 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.-

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>patients received nutrition education and nutritional supplements | Dietary Supplement: glucose control nutritional shake, nutrition education<br>* 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.<br>* Other names: Nutrition education;|
| No Intervention: Control<br>patients did not receive any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| Change in basal metabolic rate | Mean change from baseline in basal metabolic rate(kcal) at weeks 4, 8, and 12. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DFU, wound healing, nutrition education,supplementation