Phase 2 Type 1 Diabetes 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 aged 18 or older, of any gender
• People who have been diagnosed with Type 1 or Type 2 diabetes
• People who have a diabetic foot ulcer that is Grade 2, not infected, located below the ankle (but not between the toes), and has been present for at least 30 days
• People whose wound measures between 1.0 cm² and 12.0 cm² in size
• People whose wound has no exposed bone, tendon, or joint capsule, no tunneling or hidden channels, and is no deeper than 5mm
• People with more than one wound, where the largest wound is at least 1.0 cm² and is at least 2.0 cm away from any other wound
• People whose wound has not closed by more than 20% during a standard care observation period of 14 days
• People with adequate blood flow to the affected leg, confirmed by at least one of several circulation tests (confirm with trial site for specific test thresholds)
• People whose wound scores within specific ranges on a wound severity scoring system called WIfI (confirm with trial site)
• People whose wound shows no signs of infection and no dead tissue after wound cleaning
• People with a normal platelet count between 105,000 and 450,000
• People with a haemoglobin level of at least 10 g/dL and haematocrit of at least 27%
• People with a blood sugar control reading (HbA1c) of 12% or below, and who are actively being treated by a doctor to manage their diabetes
• People whose kidneys are functioning at a level above a certain threshold (eGFR of 15 or above)
• People whose blood clotting levels fall within a specific range if they are taking blood-thinning medication (INR between 2.0 and 3.0)
• People with adequate nutritional status, confirmed by a pre-albumin level above 15 mg/dL
• People who are consistently using an approved offloading boot or equivalent device to reduce pressure on the wound
• Women of childbearing potential who have a negative pregnancy test at the start of the trial and agree to use contraception or abstain from sexual activity during the trial
• Men who agree to use contraception or abstain from sexual activity during the trial
• People who are willing and able to provide written consent and follow all study procedures

Who may not be able to join:

• People with a life expectancy of less than 12 months
• People with anaemia, indicated by low haemoglobin (at or below 10 g/dL) or low haematocrit (at or below 27%)
• People whose foot ulcer is caused by something other than diabetes
• People who have taken part in another clinical trial involving a device or investigational drug within the past 30 days
• People who have had a confirmed bloodstream infection (sepsis) within the past 2 weeks
• People who have had a soft tissue infection in the same leg or at the wound site within the past 2 weeks
• People with a bone infection (osteomyelitis) at or near the wound site, identified through blood markers
• People with severe kidney failure who require dialysis
• People whose religious beliefs do not allow the use of blood products, including their own blood
• People with a history of alcohol or substance misuse (other than tobacco) within the past 2 months
• People with a blood-borne or communicable disease that would likely prevent full participation in the trial (such as HIV, AIDS, active COVID-19, or tuberculosis)
• People with severe lymphoedema (Stage 3) who are unable to lift the affected limb on their own due to swelling
• People currently undergoing haemodialysis
• People who are cognitively impaired or unable to understand and consent to the trial, or who require a healthcare proxy to make decisions on their behalf
• People with sickle cell anaemia, low platelet counts (thrombocytopenia), leukaemia, or other blood disorders
• People with a known history of blood clotting problems or abnormal platelets, or those currently receiving heparin via an intravenous drip (note: people taking oral blood thinners such as warfarin, aspirin, or clopidogrel are not automatically excluded — confirm with trial site)
• People whose anaemia may make it difficult to tolerate regular blood draws required by the study
• People who have received certain wound treatments in the past 30 days, including electrical stimulation, hyperbaric oxygen therapy, growth factors, or cell/tissue-based therapies
• People who have used systemic corticosteroids in the past 30 days (inhaled steroids for asthma or COPD are generally not excluded — confirm with trial site)
• People who have received, or are scheduled to receive, treatments known to interfere with wound healing within the past 30 days (such as immunosuppressive therapy, dialysis, radiation to the treatment area, or certain vascular procedures)
• People who have received radiation therapy or chemotherapy within the past 3 months
• People with a known sensitivity or allergy to blood components used in the treatment preparation
• People who do not have adequate vein access for the repeated blood draws needed to prepare the treatment

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