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NCT05281562
Immunonutrition for Diabetic Foot Ulcers
Phase 2, PHASE3 trial testing Lovaza in Diabetes Mellitus in 1 participant. Terminated before completion.
20 March 2023
Quick facts
| Lead sponsor | Prisma Health-Midlands |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 8 February 2023 |
| Primary completion | 20 March 2023 |
| Estimated completion | 20 March 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Diabetic Peripheral Neuropathy — all drugs for Diabetic Peripheral Neuropathy →
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
Sponsor
Prisma Health-Midlands — full company profile →
Who can join
Adults 18 to 99, any sex, with Diabetes Mellitus or Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05281562
- Europe PMC full search
- ASCO Meeting Library
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Other Prisma Health-Midlands trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05281562 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prisma Health-Midlands
- Last refreshed: 27 December 2024
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing