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
Among 29 studies in Diabetic Foot with a site in Egypt — 7 open to participants now, 8 under way, none of them phase 3. Diabetic Foot · Egypt.
Among the 29 studies in Diabetic Foot with a site in Egypt, this one is the 12th largest by planned enrollment of the 25 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 2, and was the 28th registered.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
Browse Diabetic Foot studies →7 of the 29 studies in Diabetic Foot with a site in Egypt are open now. Recruiting first, the newest first:
Al Hayah University In Cairo · Sites in Egypt
Ages 18–65
Cairo University · Sites in Egypt
Ages 50–65 · Healthy volunteers
Cairo University · Sites in Egypt
Ages 40–70
Beni-Suef University · Sites in Egypt
Ages 50–65
Cairo University · Sites in Egypt
Ages 45–55
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 137 Diabetic Foot studies recruiting now, 96 (70%) set no upper age limit and 12 (9%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 30 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Median enrollment 47 across the 25 interventional studies, 60 across the 4 observational. Of the 17 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 29 have an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 3 studies filed under Diabetic Foot — fewer than ten, so there is no comparison to draw.
2 of the studies in Diabetic Foot with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06916663Al Hayah University In CairoRCT Comparing Upper Body vs. Combined Exercise Protocols During Active Diabetic Foot Ulcer Treatment | 2027-04-23 |
| NCT07768228Ain Shams UniversityThe Effect of L-Carnitine on Wound Healing in Patients With Diabetic Foot Ulcer. | 2027-07-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 29 studies in Diabetic Foot with a site in Egypt, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Not enrolling at this site.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.
Of 31 phase 2 interventional studies under Diabetic Foot, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
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.
Studies of the drug tested here: Carnitine