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:

• The person has signed a consent form agreeing to take part in the study
• The person is aged 18 to 80 years old (male or female)
• The person is scheduled to be treated with a specific wound care product called a borate-based bioactive glass fiber matrix (BBGFM) for their diabetic foot ulcer
• The foot ulcer has not previously been treated with this BBGFM product
• Insurance coverage for the BBGFM product is in place for the person
• The person has documented Type 1 or Type 2 diabetes, with a blood sugar control measurement (HbA1c) of 12.0% or below, taken within the past 90 days
• The person is currently under a doctor's care for managing their diabetes
• The wound is located on the foot, specifically below the ankle bone, and may be on the top, bottom, between the toes, heel, or sides of the foot
• The foot ulcer measures between 0.5 cm² and 8.0 cm² in size
• The foot ulcer has been present for more than 4 weeks but less than 2 years at the time of first treatment
• The treatment will be carried out in an outpatient setting (no overnight hospital stay required)
• The foot ulcer is classified as a Wagner Grade 2 or Grade 3 wound (these are medical severity ratings — confirm details with trial site), with specific conditions around bone involvement and tissue that can be managed without an operating room
• The person does not need surgical wound cleaning that requires an operating room
• There is no active skin infection (cellulitis) around the foot ulcer
• The person, or their carer, is willing to follow the wound dressing plan and attend all study visits
• The person is willing to use a device to take pressure off the wound while it heals
• If the person can become pregnant, they must be using an accepted form of contraception and agree to continue doing so during the study
• The person has adequate blood flow to the affected foot, confirmed by at least one of several circulation tests within the past 60 days (confirm specific tests with trial site)

Who may not be able to join:

• The person is unwilling to sign the consent form
• Insurance coverage for the BBGFM product cannot be arranged for the person
• The treatment cannot be delivered in an outpatient setting for the person
• The foot ulcer has already been treated with this BBGFM product previously
• The person has had a major amputation on the opposite leg (at or above the mid-foot level)
• The person is pregnant or breastfeeding
• The foot ulcer is linked to a cancer diagnosis
• The person has active Charcot Neuroarthropathy (a serious foot and joint condition related to nerve damage)
• The person needs extensive bone or tissue removal that requires an operating room
• The person has a life expectancy of less than six months, as assessed by the trial doctor
• The person's overall health and metabolism are not considered adequately managed, in the opinion of the trial doctor
• The person has a known history of not following medical treatment plans
• The person is currently receiving cancer treatment
• The person has been taking low-dose oral steroids (less than 7.5 mg daily) for more than seven days in a row in the 30 days before screening (confirm details with trial site)
• The person has been taking steroid injections or certain immune-suppressing medicines for seven consecutive days in the 30 days before screening
• The person has had a cancer diagnosis (other than certain skin cancers) in the past five years
• The person has been diagnosed with certain serious health conditions, including cancer, lupus, vasculitis, sickle cell disease, fibromyalgia, HIV/AIDS, uncontrolled rheumatoid arthritis, or advanced kidney disease
• The person is currently receiving radiation therapy or chemotherapy
• The person is currently on dialysis or planning to start dialysis
• The person has a condition that would make it difficult to understand or follow the study requirements, in the opinion of the trial doctor
• The person is unable to consistently use an offloading device to relieve pressure on the wound
• The foot ulcer cannot be offloaded using an offloading device
• The foot ulcer involves acute (sudden/new) bone infection, as indicated by no bone changes on X-ray or the presence of an active skin infection
• The person is expected to use a vacuum-assisted wound therapy device (Negative Pressure Wound Therapy) on the ulcer during the study
• The person is permanently unable to walk and relies entirely on a wheelchair
• A woman of childbearing potential who is unwilling to avoid pregnancy or use an appropriate form of contraception during the study
• The person has a known allergy to the wound dressing materials used in this trial
• The trial doctor considers the person unsuitable for inclusion for other reasons, such as needing certain surgical treatments or currently having a serious blood infection (sepsis)

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