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Completed

NCT Number: NCT04055064

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

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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

glucose control nutritional shake, nutrition education

Dietary 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.

Other names: Nutrition education

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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.

Secondary outcomes

  1. 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.

  2. Change in basal metabolic rate

    Time frame: 12 weeks

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

  3. 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2019
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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