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

Florida State University29 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

glucose control nutritional shake, nutrition educationDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.-

Locations (1)

Florida State University

Tallahassee, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 12 weeks

Change in basal metabolic rate

Mean change from baseline in basal metabolic rate(kcal) at weeks 4, 8, and 12.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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