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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
oral L-carnitine
Faculty of Pharmacy, Ain Shams University
Cairo, Cairo Governorate, Egypt
RECRUITINGFaculty of Pharmacy, Ain Shams University
Cairo, Cairo Governorate, Egypt
ACTIVE_NOT_RECRUITINGChange in Diabetic Foot Ulcer area
Diabetic Foot Ulcer area will be measured at baseline and after 12 weeks using the ulcer length and width measurements. The change in ulcer area from baseline to 12 weeks will be assessed between the treatment (L-carnitine) and control groups. Unit of measure: cm2
Time frame: At baseline and the end of the study (after 12 weeks)
Change in Diabetic Foot Ulcer depth
Diabetic Foot Ulcer depth will be measured at baseline and after 12 weeks. The change in ulcer depth from baseline to 12 weeks will be assessed between the treatment (L-carnitine) and control groups. unit of measure: cm
Time frame: At baseline and the end of the study (after 12 weeks)
Change in Vascular endothelial growth factor (VEGF) level
Serum Vascular endothelial growth factor (VEGF) level measured at baseline and after 12 weeks of treatment. The change from baseline to 12 weeks will be assessed.
Time frame: At Baseline and the end of the study (after 12 weeks)
Change in Tumor Necrosis Factor-alpha (TNF-a) level
Serum TNF-a level measured at baseline and after 12 weeks of treatment. The change from baseline to 12 weeks will be assessed.
Time frame: At Baseline and the end of the study (after 12 weeks)
Change in Hemoglobin A1c (HbA1c) level
HbA1c level measured at baseline and after 12 weeks of treatment. The change from baseline to 12 weeks will be assessed.
Time frame: At baseline and the end of the study (after 12 weeks)
Change in Lipid profile level
The lipid parameters will be measured at baseline and after 12 weeks of treatment. The change from baseline to 12 weeks will be assessed.
Time frame: At baseline and the end of the study (after 12 weeks)
Change in Diabetes-39 Quality of Life Score.
Quality of life will be assessed using the Diabetes-39 (D-39) questionnaire at baseline and after 12 weeks of treatment. The change in the total D-39 score from baseline to 12 weeks will be assessed.
Time frame: At Baseline and the end of the study (after 12 weeks)
Number of participants with adverse events.
The number of participants experiencing adverse events during the study period will be assessed, including the type and occurrence of adverse events potentially related to L-Carnitine supplementation.
Time frame: At baseline and the end of the study (after 12 weeks)
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