Peripheral Neuropathy Trial, Recruiting

Written by an AI model from 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 between 18 and 85 years old, of any gender
• People who have been diagnosed with type 1 or type 2 diabetes for at least 12 months before the first study visit
• People who have a diabetic foot ulcer that is classified as grade 1 or 2 on a standard wound severity scale (Wagner classification)
• People whose foot ulcer, if surgically cleaned, had that cleaning done at least 7 days before the first study visit
• People whose foot ulcer measures between 1 and 25 cm² in size at the time of joining the trial
• People whose foot ulcer has been present for at least 14 days at the time of joining the trial
• People whose foot ulcer has been kept offloaded (pressure relieved) for at least 7 days at the time of joining the trial
• People whose foot ulcer is not currently infected
• People whose blood sugar control (HbA1c) is at or below a certain level at the first study visit (10% or 85.8 mmol/mol — confirm with trial site if unsure what this means for your situation)
• People who are willing and able to follow the trial's scheduled procedures
• People who are legally able to make their own decisions, can understand the study information, and are willing to sign a consent form

Who may not be able to join:

• People who have a known reason why hydrogel wound dressings (including the specific products Berovenal® or NU-GEL Hydrogel with Alginate) cannot be used on them
• People whose foot ulcer has already reduced in size by more than 20% between the first study visit and the point of joining the trial
• People whose foot ulcer is mainly caused by something other than diabetes
• People with poor blood flow to the affected foot, based on circulation tests done within 28 days before the first study visit or during the screening period
• People who have had an active Charcot foot condition (a type of joint and bone damage) or a bone infection in the affected foot within the 3 months before the first study visit
• People who have used advanced wound dressings containing growth factors, bioengineered tissues, or skin substitutes within 14 days before the first study visit, or who plan to use them during the trial
• People who have used an experimental drug or device, immune-suppressing medications (including steroid tablets), or steroid creams applied directly to the wound within 28 days before the first study visit
• People who have had chemotherapy or radiotherapy within 6 months before the first study visit
• People with a known history of bone cancer or cancer that has spread to the affected limb
• People with poor nutritional status
• People with ongoing, uncontrolled kidney, liver, heart, or other serious health conditions that could affect their safety or the trial results (as assessed by the trial doctor)
• People with a known history of not following medical instructions, or any condition that would seriously affect their ability to follow the trial's procedures
• People who are pregnant or breastfeeding
• People who could become pregnant and are not using an effective method of contraception

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