Immunonutrition for Diabetic Foot Ulcers

Stopped early · Phase 2/Phase 3

Conditions studied: Diabetes Mellitus, Diabetic Peripheral Neuropathy, Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT05281562

Run by

Prisma Health-Midlands

People needed

1

Starts

2023-02-08

Expected to finish

2023-03-20

Last updated by the study team

2024-12-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age at the time of informed consent
• Toe blood pressure (TBP) >40 mmHg
• Hemoglobin A1c <10% (measured within the previous 6 months)
• Diagnosis of diabetes mellitus
• Presence of at least one new chronic, non-healing (present for ≥4 weeks), lower extremity wound (Werner stage 2-3)
• Documented lipid panel within 3 months of study enrollment
• Documented CMP within 3 months of study enrollment
• Documented ECG within 3 months of study enrollment
• Receiving standard or care defined as sharps debridement, appropriate dressing, and offloading.

You may not qualify if…

• Allergy to fish
• Current smoker
• Currently taking any OTC supplements containing Omega-3 fatty acids, L-Arginine, or Vitamin C, or antibiotics
• Presence of at least one of the following diseases or conditions: End stage renal disease as defined by patients who have been diagnosed with Stage 4 kidney disease and are not on hemodialysis or who are on hemodialysis with a GFR consistently < 15L/min and BUN > 60, Untreated deep bone infection (osteomyelitis), Currently pregnant or breastfeeding
• Women of child-bearing potential
• Prisoners and other institutionalized individuals
• Any patients who have a legal representative to make medical decisions on their behalf or any individuals who are otherwise deemed as medically incompetent.

Where it is running

• Prisma Health — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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