A Phase 2 interventional study of L- carnitine in Diabetic Foot Ulcer and Diabetic Foot Ulcer (DFU), sponsored by Ain Shams University. Recruiting at 2 sites in Egypt. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
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:
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.
Exclusion Criteria:
To receive oral L-carnitine plus standard care therapy
Drug: L- carnitine
To receive only standard of care therapy
oral L-carnitine
Change 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)
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ain Shams University