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Immunonutrient

Vitamin C for Foot Ulcer

Phase 2 & 3
Waitlist Available
Led By J. Benjamin Jackson, MD
Research Sponsored by Prisma Health-Midlands
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will study whether a daily oral course of immunonutrients can help heal wounds in diabetic patients with chronic lower extremity ulcers better than the current standard of care.

Eligible Conditions
  • Diabetic Foot Ulcers
  • Diabetes
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Effect of supplemental immunonutrition on patient reported pain scores in patients with diabetic foot ulcers.
Effect of supplemental immunonutrition on patient satisfaction in patients with diabetic foot ulcers.
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.

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT03148236
10%
Pericarditis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vitamin C
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immunonutrition Supplementation GroupExperimental Treatment3 Interventions
Patients will receive a 6 week daily oral supply of 1.68 grams Omega-3 fatty acids, 4.5 grams L-Arginine, and 500 mg Vitamin C.
Group II: Standard of Care GroupActive Control1 Intervention
Patients will receive standard of care wound treatment as determined by a treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 fatty acids
FDA approved
Ascorbic acid
FDA approved

Find a Location

Who is running the clinical trial?

Prisma Health-MidlandsLead Sponsor
23 Previous Clinical Trials
2,825 Total Patients Enrolled
J. Benjamin Jackson, MDPrincipal InvestigatorPrisma Health-Midlands

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this research be beneficial for patients who are elderly?

"Enrollment for this clinical study is available to any person that is aged 18 or older, with the maximum age set at 99."

Answered by AI
Recent research and studies
Current Diabetes ReportsJournal
Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes
Hicks, Caitlin W., and Elizabeth Selvin. 2019. “Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes”. Current Diabetes Reports. Springer Science and Business Media LLC. doi:10.1007/s11892-019-1212-8.
Clinical NutritionJournal
The Anabolic Effect of Arginine on Proteins in Skin Wound and Muscle Is Independent of Nitric Oxide Production
Zhang, Xiao-jun, David L. Chinkes, and Robert R. Wolfe. 2008. “The Anabolic Effect of Arginine on Proteins in Skin Wound and Muscle Is Independent of Nitric Oxide Production”. Clinical Nutrition. Elsevier BV. doi:10.1016/j.clnu.2008.01.006.
Current Diabetes ReportsJournal
Epidemiology of Diabetes and Diabetes Complications in the Elderly: An Emerging Public Health Burden
Corriere, Mark, Nira Rooparinesingh, and Rita Rastogi Kalyani. 2013. “Epidemiology of Diabetes and Diabetes Complications in the Elderly: An Emerging Public Health Burden”. Current Diabetes Reports. Springer Science and Business Media LLC. doi:10.1007/s11892-013-0425-5.
American Journal of Critical CareJournal
Impact of a Nutritional Formula Enriched in Fish Oil and Micronutrients on Pressure Ulcers in Critical Care Patients
Theilla, M., B. Schwartz, J. Cohen, H. Shapiro, R. Anbar, and P. Singer. 2012. “Impact of a Nutritional Formula Enriched in Fish Oil and Micronutrients on Pressure Ulcers in Critical Care Patients”. American Journal of Critical Care. AACN Publishing. doi:10.4037/ajcc2012187.
~0 spots leftby Apr 2025
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