Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
Conditions
Keywords
L-Carnitine, Diabetic Foot Ulcer, DFU
Brief 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)
Detailed description
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.
Interventions
DRUGL- carnitine
oral L-carnitine
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
participants will be randomly assigned in a 1:1 ratio to receive either oral L-carnitine plus standard diabetic foot ulcer care or standard care alone. participants remain in their assigned treatment group throughout the 12-week study.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetic Foot Ulcer area | At baseline and the end of the study (after 12 weeks) | 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 |
| Change in Diabetic Foot Ulcer depth | At baseline and the end of the study (after 12 weeks) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vascular endothelial growth factor (VEGF) level | At Baseline and the end of the study (after 12 weeks) | 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. |
| Change in Tumor Necrosis Factor-alpha (TNF-a) level | At Baseline and the end of the study (after 12 weeks) | Serum TNF-a level measured at baseline and after 12 weeks of treatment. The change from baseline to 12 weeks will be assessed. |
| Change in Hemoglobin A1c (HbA1c) level | At baseline and the end of the study (after 12 weeks) | HbA1c level measured at baseline and after 12 weeks of treatment. The change from baseline to 12 weeks will be assessed. |
| Change in Lipid profile level | At baseline and the end of the study (after 12 weeks) | The lipid parameters will be measured at baseline and after 12 weeks of treatment. The change from baseline to 12 weeks will be assessed. |
| Change in Diabetes-39 Quality of Life Score. | At Baseline and the end of the study (after 12 weeks) | 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. |
| Number of participants with adverse events. | At baseline and the end of the study (after 12 weeks) | 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. |
Countries
Egypt
Contacts
CONTACTMariam Hosam, Bachelor degree in Pharmacy
Outcome results
None listed