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

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Dietary Supplement: glucose control nutritional shake, nutrition education

• Registration Number: NCT04055064
• Lead Sponsor: Florida State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-23
• Primary Completion: 2018-05-09
• Study Completion: 2018-05-09
• Status Verified: 2019-08
• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-12
• Last Update Submitted: 2019-08-12
• Study First Posted: 2019-08-13
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	glucose control nutritional shake, nutrition education	patients received nutrition education and nutritional supplements

Primary Outcome Measures

Name	Time	Method
Change in dietary intake of nutrients	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.
Change in inflammatory biomarkers	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
Change in lean body mass and body fat	12 weeks	Mean change from baseline in lean body mass(lb) and body fat(lb) at weeks 4, 8, and 12
Improvement in wound healing rate(mm^2/week)	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)

Secondary Outcome Measures

Name	Time	Method
Change in Ankle Brachial Index(ABI)	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.
Length of time that a wound achieves complete wound closure	12 weeks	Duration (number of days) to achieve complete wound closure from baseline assessed between both groups.
Change in basal metabolic rate	12 weeks	Mean change from baseline in basal metabolic rate(kcal) at weeks 4, 8, and 12.

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States