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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Dietary supplement: glucose control nutritional shake, nutrition education

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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 Names: Nutrition education
No Intervention: Control; patients did not receive any intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): May 9, 2018
• Study Completion (Actual): May 9, 2018

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: DFU, wound healing, nutrition education,supplementation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 2019.26726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not able to share individual participant data due to IRB requirements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No