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Immunonutrition for Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT05281562
Recruitment Status : Enrolling by invitation
First Posted : March 16, 2022
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
Prisma Health-Midlands

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, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Peripheral Neuropathy Diabetic Foot Ulcer Drug: Lovaza Drug: L-Arginine Powder Drug: Vitamin C Phase 2 Phase 3

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 mellitus: Type 1, Type 2, and Gestational. The etiology of disease may vary between types, and our current understanding notes overlap of these types, yet the resulting pathophysiology is the same: poor peripheral blood flow, decreased cellular response at the injury site, elevated glucose levels, and poor nutrient transport. Despite many of these patients having an elevated Body Mass Index (BMI), they are functionally under or malnourished. In addition, some patients develop progressive neurologic dysfunction, called peripheral neuropathy (PN). A common complication of diabetes induced PN is 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 includes shoe wear modification, self-monitoring, local wound care, brace and shoe offloading, and surgical intervention as well as more sophisticated treatments such as bioengineered cellular technologies and hyperbaric oxygen therapy. These modalities are time consuming, burdensome, costly, and often do not treat the root cause of the problem. Additionally, 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. In contrast to traditional treatment modalities, nutrition therapy has been shown to aide in healing of chronic wounds by providing essential nutrients which were not previously present in necessary amounts in diabetic patients. Nutrition therapy has proven useful in modulating inflammation and the immune response, optimizing glucose control, and attenuating the hypermetabolic response to ulcers, ultimately improving healing and recovery. Thus, 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. Wound characteristics and clinical photographs will be documented throughout the course of the study. Patient-reported pain scores, side effects, and unscheduled visits to emergency departments/urgent care centers will be recorded. Patients randomized to receive immunonutrition supplementation will complete an additional survey detailing their satisfaction with the treatment plan upon completion of their participation in the study. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive 6 weeks of oral immunonutrition supplementation, consisting of L-Arginine, Vitamin C, and Omega-3 fatty acids, in addition to standard of care for wound treatment or standard of care alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Supplemental Immunonutrition on Healing of Chronic Non-Healing Lower Extremity Ulcers in Diabetic Patients: A Pilot Study
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
No Intervention: Standard of Care Group
Patients will receive standard of care wound treatment as determined by a treating physician.
Experimental: Immunonutrition Supplementation Group
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.
Drug: Lovaza
Daily dose of 1.68grams omega-3 fatty acids, 2 Lovaza pills per day.
Other Names:
  • omega-3 fatty acids
  • omega-3-acid ethyl esters

Drug: L-Arginine Powder
Daily dose of 4.5 grams L-Arginine, powder form.
Other Names:
  • Arginine
  • 2-amino-5-guanidinopentanoic acid

Drug: Vitamin C
Daily dose of 500 mg Vitamin C, powder form.
Other Name: Ascorbic acid




Primary Outcome Measures :
  1. 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. [ Time Frame: 6 weeks ]
    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 biweekly for 6 weeks for both the standard of care group and experimental group.


Secondary Outcome Measures :
  1. Effect of supplemental immunonutrition on patient reported pain scores in patients with diabetic foot ulcers. [ Time Frame: 6 weeks ]
    Patients in both the standard of care and experimental groups will report visual analog scale (VAS) pain scores at the time of consent and weekly in either office visits with the treating physician or via phone calls with a research coordinator. The VAS scale ranges from 0-10, with a higher score indicating a higher level of pain.

  2. Effect of supplemental immunonutrition on patient satisfaction in patients with diabetic foot ulcers. [ Time Frame: 6 weeks ]
    Patients in experimental group will complete a survey detailing their satisfaction with the supplemental immunonutrition regimen following completion 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.

  3. 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. [ Time Frame: 1 year ]
    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 6 week participation in the study to assess recurrence rates of diabetic foot ulcers and to identify rate of infection, surgical intervention, and amputation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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)

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05281562


Locations
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United States, South Carolina
Prisma Health
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Prisma Health-Midlands
Investigators
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Principal Investigator: J. Benjamin Jackson, MD Prisma Health-Midlands
Additional Information:
Publications:

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Responsible Party: Prisma Health-Midlands
ClinicalTrials.gov Identifier: NCT05281562    
Other Study ID Numbers: 1876718
First Posted: March 16, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Neuromuscular Diseases
Nervous System Diseases
Ascorbic Acid
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents