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

ConditionsDiabetic Foot UlcerDiabetic Foot Ulcer (DFU)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-75
SponsorAin Shams University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • L- carnitine

    Drug

    oral L-carnitine

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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