Status:
TERMINATED
Immunonutrition for Diabetic Foot Ulcers
Lead Sponsor:
Prisma Health-Midlands
Conditions:
Diabetes Mellitus
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
PHASE3
Brief 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, am...
Detailed Description
Diabetes mellitus is one of the most prevalent chronic diseases in the world and its incidence is expected to increase over the next 20 years. Historically there are three described types of diabetes ...
Eligibility Criteria
Inclusion
- ≥ 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05281562
Start Date
February 8 2023
End Date
March 20 2023
Last Update
December 27 2024
Active Locations (1)
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1
Prisma Health
Columbia, South Carolina, United States, 29203