The Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer.

The Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer.

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)

Diabetic foot ulcer (DFU) is a major complication of diabetes that may develope as a result of multiple factors, including diabetic neuropathy, ischemia, infection and local trauma. DFU is a challenging complication that requires a multidisciplinary approaches to control blood glucose level along with standard Care of wound which will decrease the risk of amputation in participants with diabetic foot ulcers.

The investigators hypothesize that L-Carnitine supplementation may have potential benefits for participants with diabetic foot ulcers; mainly due to its antioxidant activity, its wound healing effect on damage skin, and anti-inflammatory properties.

The aim of the study is to evaluate the efficacy and safety of L-Carnitine supplementation in participants with diabetic foot ulcer. Secondary outcome is to investigate the effect of L-Carnitine supplements on; VEGF, TNF-a, Lipid profile, HbA1c, and quality of life.

This would be a randomized, open label-controlled trial where a total of 50 participants with DFU will be enrolled in the study. These participants will be randomly assigned in a 1:1 ratio in two groups: Group 1(treatment group) will include 25 participants will receive 1000mg of L-Carnitine twice daily for 12 Weeks in addition to standard therapy. Group 2(control group) will include 25 participants who will receive standard therapy. Standard treatment will include Anti -diabetic treatment (insulin or oral antidiabetic drugs), in addition to standard wound care treatment (saline and silver dressing).

A 5ml blood sample would be collected by a trained nurse at baseline and after 12 weeks to assess its effect on VEGF, TNF-a, Lipid profile, and HbA1c.

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.