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

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT04055064

Run by

Florida State University

People needed

29

Starts

2017-05-23

Expected to finish

2018-05-09

Last updated by the study team

2019-08-13

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.-

Where it is running

• Florida State University — Tallahassee, Florida, United States

Full record on ClinicalTrials.gov

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