Diabetic Foot UlcerPhase 2NCT07768228
The Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer.
A Phase 2 study testing L- carnitine in people with Diabetic Foot Ulcer and Diabetic Foot Ulcer (DFU), run by Ain Shams University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
- What is being tested?
- L- carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2026to 1 Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 1 recruiting
- Recruiting
Faculty of Pharmacy, Ain Shams University
Cairo, Cairo Governorate, 11566
- Active, not recruiting
Faculty of Pharmacy, Ain Shams University
Cairo, Cairo Governorate, 11566
About this study
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:
- Vascular endothelial growth factor (VEGF)
- Inflammatory markers TNF-a (Tumor necrosis factor alpha).
- Hemoglobin A1C (HbA1c) And Lipid profile (cholesterol, triglycerides, high-density Lipoprotein (HDL) and low-density lipoprotein (LDL)).
- To assess the type and likelihood of any adverse drug reaction that can be related to L-Carnitine supplementation.
- QOL (DIABETES 39)
Read the 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.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
- Being tested
- L- carnitine
- Keywords
- L-Carnitine, Diabetic Foot Ulcer, DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L- carnitineDrug
oral L-carnitine
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | To receive oral L-carnitine plus standard care therapy Receives: Drug: L- carnitine |
| Control | No intervention | To receive only standard of care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At baseline and the end of the study (after 12 weeks)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline and the end of the study (after 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768228
- Sponsor's protocol ID
- L-Carnitine in DFU
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39114278Scioli 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.
PubMed 26473356Fathizadeh 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.
PubMed 31611746Yahyapoor 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.
PubMed 35623869Galiano 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.
PubMed 15161630Nasole 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.
PubMed 23360079Dworzanski 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.
PubMed 32210468Deng 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.
PubMed 33628388Armstrong 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.
PubMed 11375363Armstrong 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.
PubMed 15306986Golbidi 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.
PubMed 22125537