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NCT05281562 · ClinicalTrials.gov registry record · Phase 2
Immunonutrition for Diabetic Foot Ulcers
A Phase 2 study, sponsored by Prisma Health-Midlands.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT05281562: Clinical Trial Phase 2 study, sponsored by Prisma Health-Midlands.
NCT05281562 is a Phase 2 study that was terminated before completion, run by Prisma Health-Midlands. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05281562, a Phase 2 study, was terminated before completion, sponsored by Prisma Health-Midlands.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Diabetes-induced peripheral neuropathy can lead to the development of diabetic foot ulcers (DFUs), which can have a devastating effect on patients' lives and can lead to life threatening infection, amputations, and even death. Conventional treatment of DFUs are time consuming, burdensome, costly, and often do not treat the root cause of the problem. Even with proper care, ulcers can take a significantly longer time to heal in diabetic patients due to the altered physiology which does not allow for the proper nutrients and healing factors to mobilize to the site of injury, leaving these ulcers with a poor chance of healing and at high risk for infection and possible amputation. Supplemental immunonutrition therapy may offer a viable, low cost, rapidly scalable, and widely available approach to enhance the body's ability to heal itself. This prospective, randomized pilot study will evaluate the effect of a 6-week daily oral course of a specific combination of immunonutrients, L-Arginine, Omega-3 fatty acids, and Vitamin C, on wound healing in diabetic patients with chronic lower extremity ulcers compared to traditional standard of care. The deliverables of this clinical project will serve to advance a cost-effective added strategy to address a significant unmet clinical need in treatment for the diabetic patient population. Study outcomes will lay the foundation for a multi-site clinical trial to establish the efficacy and cost-effectiveness of this strategy across the health care system.
Primary Outcome
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
Interventions
- DRUG Vitamin C
- DRUG Lovaza
- DRUG L-Arginine Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-02-08 |
| Est. Completion | 2023-03-20 |
| Phase | Phase 2 |
Why NCT05281562 stopped before completion
NCT05281562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Vitamin C is the first listed.
NCT05281562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05281562 about?
NCT05281562 is a clinical study titled "Immunonutrition for Diabetic Foot Ulcers". Diabetes-induced peripheral neuropathy can lead to the development of diabetic foot ulcers (DFUs), which can have a devastating effect on patients' lives and can lead to life threatening infection, amputations, and even death. Conventional treatment of DFUs are time consuming, burdensome, costly, an...
What is the current status of trial NCT05281562?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2023-02-08. Estimated completion is 2023-03-20.
What interventions are being tested in trial NCT05281562?
The interventions under investigation include: Vitamin C (DRUG), Lovaza (DRUG), L-Arginine Powder (DRUG).
Who is sponsoring clinical trial NCT05281562?
This trial is sponsored by Prisma Health-Midlands, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05281562's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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