Status:
COMPLETED
The Effects of Nutrition Supplementation and Education on the Healing of Diabetic Foot Ulcer (DFU)
Lead Sponsor:
Florida State University
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
30-70 years
Phase:
NA
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 intak...
Eligibility Criteria
Inclusion
- 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
- 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.-
Key Trial Info
Start Date :
May 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2018
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04055064
Start Date
May 23 2017
End Date
May 9 2018
Last Update
August 13 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida State University
Tallahassee, Florida, United States, 32306