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

NCT04055064 | Completed

• 1 other identifier: 2019.26726
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

DFU, wound healing, nutrition education,supplementation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Length of time that a wound achieves complete wound closure

  12 weeks

• Change in basal metabolic rate

  12 weeks

• Change in Ankle Brachial Index(ABI)

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

patients received nutrition education and nutritional supplements

Dietary Supplement: glucose control nutritional shake, nutrition education

Control

NO INTERVENTION

patients did not receive any intervention

Interventions

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.

Also known as: Nutrition education

Intervention

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: May 23, 2017
• Primary Completion: May 9, 2018
• Study Completion: May 9, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)