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

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Florida State University

Status

Completed

Conditions

Diabetic Foot Ulcer

Treatments

Dietary Supplement: glucose control nutritional shake, nutrition education

Study type

Interventional

Funder types

Other

Identifiers

NCT04055064
2019.26726

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No 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.-

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

29 participants in 2 patient groups

Intervention
Experimental group
Description:
patients received nutrition education and nutritional supplements
Treatment:
Dietary Supplement: glucose control nutritional shake, nutrition education
Control
No Intervention group
Description:
patients did not receive any intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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