Peripheral Neuropathy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 or over, of any ethnic background, who have been diagnosed with type 1 or type 2 diabetes
- People whose blood sugar control meets a specific level — a blood test result called HbA1c at or below 10% — measured within the past 3 months or at the first study visit
- People whose fasting blood sugar level is below 300 mg/dl
- People who have a long-lasting diabetic foot wound below the ankle, between 2 and 40 cm² in size, with a maximum length of 10 cm, that has not started healing within 4 weeks or has not fully healed within 8 weeks of standard care
- People whose foot wound reaches a certain depth into the tissue (classified as grade 2 or higher on a medical scale called PEDIS), but does not involve bone
- People whose foot wound shows signs of infection at a specific level (grade 2 on the PEDIS infection scale), confirmed by a doctor's examination
- People who are able to swallow and take tablets or capsules by mouth
- People who are willing and able to follow all study visits and procedures
- People who are willing to sign a consent form before any study activities begin
Who may not be able to join:
- People who are unable to give written consent to participate
- People who are pregnant or currently breastfeeding
- People who are capable of becoming pregnant and are not using an adequate form of contraception (confirm with trial site)
- People who have taken part in another clinical trial or received an experimental treatment within the 30 days before the first study visit
- People whose blood circulation in the affected leg is significantly reduced, as measured by a specific blood pressure test (ankle brachial index below 0.5)
- People whose foot wound is found to reach the bone when tested by a doctor
- People who have any surgery planned during the period covered by the study
- People who have been diagnosed with poor blood circulation in the legs (peripheral vascular disease) that requires a procedure or surgery to restore blood flow
- People whose oxygen levels in the skin near the wound are very low, as measured by a specific test (transcutaneous oximetry below 30 mmHg)
- People who have used any antibiotic treatment — whether applied to the skin or taken by mouth — within 48 hours before the first study visit
- People for whom a small skin sample procedure (punch biopsy) is not medically appropriate
- People who are unable to take the antibiotic combination amoxicillin and clavulanic acid at the doses required by the study
- People who cannot be treated with an iodine-based antiseptic product (iodopovidone) due to a known contraindication
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 0557361193
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
To assess the ulcer after 2 weeks of study treatment by evaluation of the following primary endpoint:
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.