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

Primary Purpose

Diabetic Foot Ulcer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

glucose control nutritional shake, nutrition education

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring DFU, wound healing, nutrition education,supplementation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.-

Sites / Locations

Florida State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

patients received nutrition education and nutritional supplements

patients did not receive any intervention

Outcomes

Primary Outcome Measures

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)

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

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

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.

Secondary Outcome Measures

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.

Change in basal metabolic rate

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

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.

Full Information

NCT ID

NCT04055064

First Posted

August 9, 2019

Last Updated

August 12, 2019

Sponsor

Florida State University

1. Study Identification

Unique Protocol Identification Number

NCT04055064

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

May 23, 2017 (Actual)

Primary Completion Date

May 9, 2018 (Actual)

Study Completion Date

May 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

Keywords

DFU, wound healing, nutrition education,supplementation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

patients received nutrition education and nutritional supplements

Arm Title

Control

Arm Type

No Intervention

Arm Description

patients did not receive any intervention

Intervention Type

Dietary Supplement

Intervention Name(s)

glucose control nutritional shake, nutrition education

Other Intervention Name(s)

Nutrition education

Intervention Description

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.

Primary Outcome Measure Information:

Title

Improvement in wound healing rate(mm^2/week)

Description

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)

Time Frame

12 weeks

Title

Change in inflammatory biomarkers

Description

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

Time Frame

12 weeks

Title

Change in lean body mass and body fat

Description

Mean change from baseline in lean body mass(lb) and body fat(lb) at weeks 4, 8, and 12

Time Frame

12 weeks

Title

Change in dietary intake of nutrients

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Length of time that a wound achieves complete wound closure

Description

Duration (number of days) to achieve complete wound closure from baseline assessed between both groups.

Time Frame

12 weeks

Title

Change in basal metabolic rate

Description

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

Time Frame

12 weeks

Title

Change in Ankle Brachial Index(ABI)

Description

Mean change from baseline in ABI by comparing the blood pressure in the upper and lower limbs at weeks 4,8, and 12.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.-

Facility Information:

Facility Name

Florida State University

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32306

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

not able to share individual participant data due to IRB requirements

Learn more about this trial

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

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