L-Carnitine as an add-on for healing diabetic foot ulcers
Official title: The Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer.
Run by Ain Shams University · NCT07768228 · Data updated 2026-11-12
This study tests whether taking L-Carnitine helps wound healing in adults with diabetic foot ulcers, alongside standard diabetes and wound care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo, Cairo Governorate and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07768228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 30-75 with diabetic neuropathy and Wagner grade 1-2 DFU, on stable antidiabetic therapy, and with HbA1c under control.
✕Probably not a fit
Patients with non-neuropathic ulcers, severe ulcers (Wagner 3+), significant liver or kidney disease, or those taking certain antioxidants or cancer therapies may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, open-label phase 2 trial enrolling 50 adults with diabetic neuropathy and mild to moderate diabetic foot ulcers (Wagner 1-2). Participants are assigned 1:1 to receive either 1000 mg of L-Carnitine twice daily plus standard therapy or standard therapy alone for 12 weeks. Primary outcomes measure changes in ulcer length and depth, while secondary outcomes examine VEGF, TNF-alpha, HbA1c, lipid profile, adverse reactions, and quality of life. The study aims to determine the safety and potential wound-healing benefits of L-Carnitine as an adjunct to conventional care. The lead sponsor is Ain Shams University, with study activities conducted at Ain Shams University in Cairo.
Why it matters
Potential benefit: If successful, L-Carnitine could improve wound healing and provide broader metabolic and inflammatory benefits for DFU patients.
How similar studies have gone: Prior approaches using antioxidant or metabolic adjuncts have shown mixed results; this trial tests a specific L-Carnitine regimen in DFU with primary wound outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult Male or Female patients with diabetic neuropathy mean age (30-75) years old. * Having Diabetic neuropathy and Diabetic foot ulcer grade 1-2 (mild- moderate) according to Wagner classification. * Uncontrolled diabetic patients (HbA1c). \< 9 duration of diabetic (5 - 10) years. * All patient treated with stable dose of anti-diabetic medication priors and during the period of the study. Exclusion Criteria: * Patients with other causes of ulcers. * Patient taking any antioxidant supplements including vitamin E, ascorbic acid, omega 3 fatty acid, Coenzyme Q10 within three months prior to enrollment in the study. * Patient with autoimmune disease. * Patient with liver disease or kidney disease. * Patient taking medications for cancer. * Patient with thyroid disease.
Where it's running
-
Faculty of Pharmacy, Ain Shams University
Cairo, Cairo Governorate, Egypt Recruiting -
Faculty of Pharmacy, Ain Shams University
Cairo, Cairo Governorate, Egypt Active not recruiting
Study contacts
- Study coordinator: Mariam Hosam, Bachelor degree in Pharmacy
- Email: Mariam.hossam@pharma.asu.edu.eg
- Phone: 2+ 01115772704
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.