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

NCT07768228 | Recruiting Phase 2

• 1 other identifier: L-Carnitine in DFU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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. 1.Vascular endothelial growth factor (VEGF)
2. 2.Inflammatory markers TNF-a (Tumor necrosis factor alpha).
3. 3.Hemoglobin A1C (HbA1c) And Lipid profile (cholesterol, triglycerides, high-density Lipoprotein (HDL) and low-density lipoprotein (LDL)).
4. 4.To assess the type and likelihood of any adverse drug reaction that can be related to L-Carnitine supplementation.
5. 5.QOL (DIABETES 39)

Conditions

Diabetic Foot Ulcer; Diabetic Foot Ulcer (DFU)

Keywords

L-Carnitine; Diabetic Foot Ulcer; DFU

Outcome Measures

Primary Outcomes (2)

• 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

  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

  At baseline and the end of the study (after 12 weeks)

Secondary Outcomes (6)

• Change in Vascular endothelial growth factor (VEGF) level

  At Baseline and the end of the study (after 12 weeks)

• Change in Tumor Necrosis Factor-alpha (TNF-a) level

  At Baseline and the end of the study (after 12 weeks)

• Change in Hemoglobin A1c (HbA1c) level

  At baseline and the end of the study (after 12 weeks)

• Change in Lipid profile level

  At baseline and the end of the study (after 12 weeks)

• Change in Diabetes-39 Quality of Life Score.

  At Baseline and the end of the study (after 12 weeks)

Study Arms (2)

Treatment

EXPERIMENTAL

To receive oral L-carnitine plus standard care therapy

Drug: L- carnitine

Control

NO INTERVENTION

To receive only standard of care therapy

Interventions

L- carnitine DRUG

oral L-carnitine

Treatment

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Faculty of Pharmacy, Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

RECRUITING

Faculty of Pharmacy, Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

ACTIVE NOT RECRUITING

Related Publications (11)

• Aldendail CF, Chen P, Dibble HS, Baute Penry V. A Comprehensive Review of Safety, Efficacy, and Indications for the Use of Alpha-Lipoic Acid and Acetyl-L-Carnitine in Neuropathic Pain. Integr Med (Encinitas). 2024 Jul;23(3):32-39.

  PMID: 39114278 BACKGROUND

• Scioli MG, Lo Giudice P, Bielli A, Tarallo V, De Rosa A, De Falco S, Orlandi A. Propionyl-L-Carnitine Enhances Wound Healing and Counteracts Microvascular Endothelial Cell Dysfunction. PLoS One. 2015 Oct 16;10(10):e0140697. doi: 10.1371/journal.pone.0140697. eCollection 2015.

  PMID: 26473356 BACKGROUND

• Fathizadeh H, Milajerdi A, Reiner Z, Kolahdooz F, Asemi Z. The effects of L-carnitine supplementation on glycemic control: a systematic review and meta-analysis of randomized controlled trials. EXCLI J. 2019 Aug 19;18:631-643. doi: 10.17179/excli2019-1447. eCollection 2019.

  PMID: 31611746 BACKGROUND

• Yahyapoor F, Sedaghat A, Feizi A, Bagherniya M, Pahlavani N, Khadem-Rezaiyan M, Safarian M, Islam MS, Zarifi SH, Arabi SM, Norouzy A. The effects of l-Carnitine supplementation on inflammatory markers, clinical status, and 28 days mortality in critically ill patients: A double-blind, randomized, placebo-controlled trial. Clin Nutr ESPEN. 2022 Jun;49:61-67. doi: 10.1016/j.clnesp.2022.04.001. Epub 2022 Apr 9.

  PMID: 35623869 BACKGROUND

• Galiano RD, Tepper OM, Pelo CR, Bhatt KA, Callaghan M, Bastidas N, Bunting S, Steinmetz HG, Gurtner GC. Topical vascular endothelial growth factor accelerates diabetic wound healing through increased angiogenesis and by mobilizing and recruiting bone marrow-derived cells. Am J Pathol. 2004 Jun;164(6):1935-47. doi: 10.1016/S0002-9440(10)63754-6.

  PMID: 15161630 BACKGROUND

• Nasole E, Nicoletti C, Yang ZJ, Girelli A, Rubini A, Giuffreda F, Di Tano A, Camporesi E, Bosco G. Effects of alpha lipoic acid and its R+ enantiomer supplemented to hyperbaric oxygen therapy on interleukin-6, TNF-alpha and EGF production in chronic leg wound healing. J Enzyme Inhib Med Chem. 2014 Apr;29(2):297-302. doi: 10.3109/14756366.2012.759951. Epub 2013 Jan 30.

  PMID: 23360079 BACKGROUND

• Dworzanski J, Strycharz-Dudziak M, Kliszczewska E, Kielczykowska M, Dworzanska A, Drop B, Polz-Dacewicz M. Glutathione peroxidase (GPx) and superoxide dismutase (SOD) activity in patients with diabetes mellitus type 2 infected with Epstein-Barr virus. PLoS One. 2020 Mar 25;15(3):e0230374. doi: 10.1371/journal.pone.0230374. eCollection 2020.

  PMID: 32210468 BACKGROUND

• Deng L, Du C, Song P, Chen T, Rui S, Armstrong DG, Deng W. The Role of Oxidative Stress and Antioxidants in Diabetic Wound Healing. Oxid Med Cell Longev. 2021 Feb 4;2021:8852759. doi: 10.1155/2021/8852759. eCollection 2021.

  PMID: 33628388 BACKGROUND

• Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001 Jun;24(6):1019-22. doi: 10.2337/diacare.24.6.1019.

  PMID: 11375363 BACKGROUND

• Armstrong DG, Lavery LA, Nixon BP, Boulton AJ. It's not what you put on, but what you take off: techniques for debriding and off-loading the diabetic foot wound. Clin Infect Dis. 2004 Aug 1;39 Suppl 2:S92-9. doi: 10.1086/383269.

  PMID: 15306986 BACKGROUND

• Golbidi S, Badran M, Laher I. Diabetes and alpha lipoic Acid. Front Pharmacol. 2011 Nov 17;2:69. doi: 10.3389/fphar.2011.00069. eCollection 2011.

  PMID: 22125537 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Central Study Contacts

Mariam Hosam, Bachelor degree in Pharmacy

CONTACT

2+ 01115772704; Mariam.hossam@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)