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

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ClinicalTrials.gov Identifier: NCT04055064
Recruitment Status : Completed
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Raedeh Basiri, 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Dietary Supplement: glucose control nutritional shake, nutrition education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effects of Improving Nutritional Intake on Wound Healing in Patients With Diabetic Foot Ulcer
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : May 9, 2018
Actual Study Completion Date : May 9, 2018

Resource links provided by the National Library of Medicine


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 Name: Nutrition education

No Intervention: Control
patients did not receive any intervention



Primary Outcome Measures :
  1. Improvement in wound healing rate(mm^2/week) [ Time Frame: 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)


  2. Change in inflammatory biomarkers [ Time Frame: 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

  3. Change in lean body mass and body fat [ Time Frame: 12 weeks ]
    Mean change from baseline in lean body mass(lb) and body fat(lb) at weeks 4, 8, and 12

  4. Change in dietary intake of nutrients [ Time Frame: 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.


Secondary Outcome Measures :
  1. Length of time that a wound achieves complete wound closure [ Time Frame: 12 weeks ]
    Duration (number of days) to achieve complete wound closure from baseline assessed between both groups.

  2. Change in basal metabolic rate [ Time Frame: 12 weeks ]
    Mean change from baseline in basal metabolic rate(kcal) at weeks 4, 8, and 12.

  3. Change in Ankle Brachial Index(ABI) [ Time Frame: 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.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055064


Locations
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United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University

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Responsible Party: Raedeh Basiri, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier: NCT04055064     History of Changes
Other Study ID Numbers: 2019.26726
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not able to share individual participant data due to IRB requirements

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Raedeh Basiri, Florida State University:
DFU, wound healing, nutrition education,supplementation

Additional relevant MeSH terms:
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Diabetes Complications
Diabetes Mellitus
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases