Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 years or older.
• People who are able to understand what the study involves and are willing to sign a written consent form.
• If a person has more than one wound that could qualify, the trial site will select one wound (usually the largest or most significant) to focus on during the study.

For people with venous leg ulcers (VLUs) specifically:

• People who have been diagnosed with at least one venous leg ulcer.
• People whose ulcer has been present for between 6 weeks and 3 years at the time of screening.
• People whose ulcer has been slow to heal — meaning the wound size decreased by less than 40% over a four-week lead-in period before the trial starts.
• People whose ulcer measures between 5 and 25 cm² in size.
• People whose ulcer shows no signs of active infection at the time of joining (confirm with trial site regarding how this is assessed).
• People who have adequate blood flow to the affected leg, confirmed by standard circulation tests at clinical examination.

For people with diabetic foot ulcers (DFUs) specifically:

• People who have been diagnosed with type 1 or type 2 diabetes.
• People who have at least one diabetic foot ulcer located on the foot below the ankle, not including wounds located only between the toes.
• People whose ulcer has been present for between 4 weeks and 3 years at the time of screening.
• People whose ulcer has been slow to heal — meaning the wound size decreased by less than 50% over a four-week lead-in period before the trial starts.
• People whose ulcer measures between 1 and 25 cm² in size.
• People whose ulcer shows no signs of active infection at the time of joining.
• People whose blood sugar control measure (HbA1c) is below 12% at screening.
• People who have adequate blood flow to the affected leg, confirmed by standard circulation tests.

Who may not be able to join:

• People with a history of end-stage kidney disease, dialysis, or severely reduced kidney function.
• People with a history of uncontrolled heart failure.
• People with a history of severe malnutrition or severe liver disease.
• People with a history of aplastic anaemia (a condition affecting blood cell production).
• People with a current or recent history of cancer (within the past 5 years).
• People with a history of rheumatoid arthritis, sickle cell disease, or other connective tissue disorders.
• People who have had radiation treatment to the affected limb.
• People with a blood sugar control measure (HbA1c) above 12%.
• People with a history of drug or alcohol misuse.
• People with very limited mobility or who are completely immobile.
• People who are known to be pregnant or breastfeeding at the time of screening.
• People currently taking or scheduled to take a medication that the trial doctor believes may affect wound healing (within 30 days before joining).
• People whose wound extends as deep as tendon, muscle, joint capsule, or bone.
• People showing signs of an active infection, either in the wound or elsewhere in the body.
• People with a known sensitivity or allergy to silicone or porcine (pig-derived) gelatin.
• People who have received treatment with growth factors, stem cells, or similar preparations within 8 weeks before the trial baseline visit.
• People who have taken part in another interventional clinical trial within 4 weeks before the baseline visit.
• People who the investigator determines may not be able to understand the study or provide informed consent.
• People whose wound increased in size by 20% or more during the lead-in period.

For people with venous leg ulcers (VLUs) specifically:

• People with a history of not following compression therapy as directed.
• People with nerve damage (neuropathy) in the lower limbs.

For people with diabetic foot ulcers (DFUs) specifically:

• People with a history of not following offloading therapy (pressure-relieving treatment) as directed.

Important: Always verify eligibility with the trial site directly before applying.