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NCT07768228
The Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer.
Conditions: Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
Sex: All
Ages: 30 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: Ain Shams University
Location: Faculty of Pharmacy, Ain Shams University Cairo Cairo Governorate
Summary
Primary outcome: To evaluate the efficacy of L-Carnitine supplementation on length and depth ulcer size
Secondary outcome: To investigate the effect of L-Carnitine supplements on:
1. Vascular endothelial growth factor (VEGF)
2. Inflammatory markers TNF-a (Tumor necrosis factor alpha).
3. Hemoglobin A1C (HbA1c) And Lipid profile (cholesterol, triglycerides, high-density Lipoprotein (HDL) and low-density lipoprotein (LDL)).
4. To assess the type and likelihood of any adverse drug reaction that can be related to L-Carnitine supplementation.
5. QOL (DIABETES 39)
Eligibility 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.
Source: ClinicalTrials.gov (NCT07768228). StuddyBuddy aggregates publicly available trial information.
