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Clinical Trial Details

Trial ID: L2762
Source ID: NCT05281562
Associated Drug: Lovaza
Title: Immunonutrition for Diabetic Foot Ulcers
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05281562/results
Conditions: Diabetes Mellitus|Diabetic Peripheral Neuropathy|Diabetic Foot Ulcer
Interventions: DRUG: Lovaza|DRUG: L-Arginine Powder|DRUG: Vitamin C
Outcome Measures: Primary: Effect of Supplemental Immunonutrition on Wound Healing in Patients With Diabetic Foot Ulcers as Assessed by the Pressure Ulcer Scale for Healing (PUSH) Tool 3.0., The PUSH Tool 3.0 will be used to score ulcers based on size (cm2), exudate amount, and tissue type present. The score ranges for size, exudate amount, and tissue type are 0-10, 0-3, and 0-4, respectively. For all categories, a higher score indicates a more severe ulcer. The score for each category is combined to generate a final score ranging from 0-17. A higher final score indicates a more severe ulcer. The treating physician will record ulcer scores using this tool at the time of consent and 6 weeks for both the standard of care group and experimental group and calculate the change in ulcer scores from consent to 6 weeks., 6 weeks|Effect of Supplemental Immunonutrition on Patient Reported Pain Scores in Patients With Diabetic Foot Ulcers., Patients in both the standard of care and experimental groups will report visual analog scale (VAS) pain scores at 6 weeks., 6 weeks | Secondary: Effect of Supplemental Immunonutrition on Patient Satisfaction in Patients With Diabetic Foot Ulcers., Patients in experimental group will complete a survey detailing their satisfaction with the supplemental immunonutrition regimen following completion of study participation. Patients will be asked to rate their satisfaction from very satisfied to very unsatisfied and questions regarding their likelihood to partake in the same treatment regimen for a subsequent ulcer, recommend this treatment regimen to others, and the level of difficulty associated with taking the supplementation., 6 weeks|Long Term Effect of Supplemental Immunonutrition on Wound Healing in Patients With Diabetic Foot Ulcers on Rates of Ulcer Recurrence, Infection, Surgical Intervention, and Amputation., Study participants in both the standard of care and experimental groups will be monitored via chart review for one year following the completion of their study participation to assess recurrence rates of diabetic foot ulcers and to identify rate of infection, surgical intervention, and amputation., 1 year
Sponsor/Collaborators: Sponsor: Prisma Health-Midlands
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 1
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-08
Completion Date: 2023-03-20
Results First Posted: 2024-12-27
Last Update Posted: 2024-12-27
Locations: Prisma Health, Columbia, South Carolina, 29203, United States
URL: https://clinicaltrials.gov/show/NCT05281562