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:

• People who are at least 18 years old.
• People whose wound has been present for more than 4 weeks but has received less than 1 year of documented medical treatment at the time of joining.
• People whose wound measures between 1.0 cm² and 25 cm² at the first screening visit.
• People who are willing and able to attend weekly visits for the study.
• People who have read and signed the required consent form before any study-specific screening begins.

For diabetic foot ulcers (DFUs) specifically, the wound must also meet these criteria:

• The wound is classified as Wagner Grade 1 or 2 (a wound grading system for diabetic foot ulcers), which may include wounds reaching ligaments, tendons, joint capsules, or fascia (confirm with trial site).
• The wound does not have an abscess (pocket of infection) or bone infection.
• If more than one diabetic foot ulcer is present, the largest one will be studied, and any other ulcers on the same foot must be more than 2 cm away from it.
• The wound has been protected from pressure and weight-bearing (offloaded) for at least 14 days before joining the study.
• Blood flow to the affected foot has been confirmed as adequate through specific circulation tests within 3 months of the first screening visit (confirm with trial site for which test applies).

For venous leg ulcers (VLUs) specifically:

• The wound is classified under an accepted venous leg ulcer grading system, except for certain excluded types listed below.
• If more than one venous leg ulcer is present, the largest one will be studied, and any other ulcers on the same leg must be more than 2 cm away from it.
• Blood flow to the affected leg has been confirmed as adequate through specific circulation tests within 3 months of the first screening visit (confirm with trial site for which test applies).

For surgically reopened wounds (surgical dehiscence) specifically:

• The wound is classified under the Sandy Grading System, except for certain excluded grades listed below.

For traumatic wounds specifically:

• The wound is classified under an accepted wound classification system, excluding the most severely infected categories (Class IV dirty infected wounds and deep or organ-space surgical site infections).

Who may not be able to join:

• People whose wound is suspected to be cancerous or has been diagnosed as cancerous.
• People who have used immune-suppressing medications (including steroid tablets at doses above 10 mg per day), chemotherapy, or steroid creams applied directly to the wound for more than two weeks in the month before screening, or who are expected to need these medications during the study.
• People currently taking a COX-2 inhibitor medication (such as Celecoxib) for any reason.
• People who have taken part in another clinical drug or device trial within 30 days before the first screening visit.
• People who have had radiation treatment at the wound site at any point in the past.
• People whose wound has previously been treated with, or will need to be treated with, therapies that are not permitted in this study (confirm with trial site for the full list).
• People with a prior diagnosis of HIV, Hepatitis C, or other contagious diseases.
• People with any condition that would seriously affect their ability to complete the study, or who have a known history of not following medical treatment as directed.
• People who are pregnant or breastfeeding.
• People with diabetes whose blood sugar has been poorly controlled, as shown by an HbA1c blood test result above 12.0% within 90 days of joining.
• People with advanced kidney disease, shown by a specific blood test result above a certain level within 6 months of joining (confirm with trial site for exact value).
• People with a BMI (body mass index) above 55.
• People whose wound size changes by more than 30% between the first and second screening visits (for diabetic foot ulcers).
• People with a Wagner Grade 2 diabetic foot ulcer that requires removal of infected bone tissue.
• People with a confirmed bone infection of the affected foot, verified by X-ray, CT scan, or MRI within 30 days before joining (for diabetic foot ulcers).

For venous leg ulcers, people may not be able to join if their ulcer involves:

• A blood clot-related (post-thrombotic) cause.
• Venous obstruction (blocked veins).
• Venous obstruction combined with backward blood flow (reflux).
• A skin condition called lipodermatosclerosis or atrophie blanche (confirm with trial site).
• A confirmed bone infection of the affected leg verified by imaging within 30 days before joining.

For surgically reopened wounds, people may not be able to join if the wound is:

• A Grade 3 wound where internal organs are exposed, or Grade 3a where the infection is considered severe by the lead doctor.

For traumatic wounds, people may not be able to join if the wound is classified as:

• Class IV (dirty, infected wounds) or a deep surgical site infection involving internal organs or spaces.

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