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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055064
• Other study ID #: 2019.26726
• Status: Completed
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: May 9, 2018

Study information

• Verified date: August 2019
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 9, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.-

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change in basal metabolic rate	Mean change from baseline in basal metabolic rate(kcal) at weeks 4, 8, and 12.	12 weeks
Secondary	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