Type 2 Diabetes 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:

This trial has two groups: one for diabetic foot ulcers (DFU) and one for venous leg ulcers (VLU). The criteria are listed separately below.

DIABETIC FOOT ULCER (DFU) GROUP

Who might be able to join this trial:

• People who are 18 years of age or older
• People who have been diagnosed with type 1 or type 2 diabetes
• People whose foot wound measures between 0.7 cm² and 20 cm² after wound cleaning
• People whose foot wound has been present for at least 4 weeks but no longer than 52 weeks before the screening visit
• People whose wound is located on the foot, with at least half of the wound below the ankle bone
• People whose wound goes through at least the skin's deeper layers or fat tissue, but does not expose any tendon or bone (confirm with trial site for exact wound grade)
• People whose affected leg has been confirmed to have adequate blood flow through one of several accepted vascular tests done within the past 3 months (confirm with trial site)
• People with more than one wound on the foot, provided the wounds are at least 2 cm apart — the largest wound meeting all criteria will be used as the focus of the study
• People whose wound is located on the sole of the foot and has been kept off-loaded (pressure relieved) for at least 14 days before joining
• People who agree to use the pressure-relief method prescribed by the study team for the full duration of the study
• People who agree to attend weekly study visits
• People who are willing and able to take part in the consent process

Who may not be able to join:

• People with a life expectancy of less than 6 months
• People whose foot wound is not caused by diabetes
• People whose wound is currently infected, or who have a skin infection (cellulitis) around the wound
• People whose wound exposes tendon or bone
• People who have a bone infection (osteomyelitis) related to the wound
• People who have an infection in the wound or elsewhere in the body that requires antibiotic tablets or injections
• People who are taking immune-suppressing medications, including steroid tablets at doses above 10 mg of prednisone per day, chemotherapy drugs, or other medications the study doctor believes may slow wound healing (such as certain biologics)
• People who are taking a medication called hydroxyurea
• People who have applied steroid creams or ointments directly to the wound within the past month
• People who have had a partial foot amputation on the affected foot that makes it difficult to properly relieve pressure from the wound
• People whose blood sugar control measure (HbA1c) was 12% or higher within the past 3 months
• People whose wound has already shrunk by more than 20% in the 2 weeks before the screening visit
• People whose wound shrinks by 20% or more during the 2-week screening period
• People who have an active or inactive Charcot foot condition that makes it difficult to properly relieve pressure from the wound
• Women who are pregnant or planning to become pregnant within the next 6 months
• People who have end-stage kidney disease requiring dialysis
• People who have taken part in another clinical trial using an experimental treatment within the past 30 days
• People who, in the study doctor's opinion, have a medical or psychological condition that could affect study results
• People who have received hyperbaric oxygen therapy or a specialised wound product (called a CAMP) within the past 30 days
• People who score below 17 on a standard malnutrition screening tool called the Mini Nutritional Assessment

VENOUS LEG ULCER (VLU) GROUP

Who might be able to join this trial:

• People who are 18 years of age or older
• People whose leg wound measures between 0.7 cm² and 20 cm² after wound cleaning at the time of enrolment
• People whose leg wound has been present for at least 4 weeks but no longer than 52 weeks before the screening visit
• People whose wound shows no clear signs of healing on its own — specifically, less than 40% reduction in wound size over the past 4 weeks
• People whose affected leg has been confirmed to have adequate blood flow through one of several accepted vascular tests done within the past 3 months (confirm with trial site)
• People with more than one wound on the affected leg, provided the wounds are at least 2 cm apart after wound cleaning — the largest wound meeting all criteria will be used as the focus of the study
• People who agree to attend weekly study visits
• People who are willing and able to take part in the consent process

Who may not be able to join:

• People with a life expectancy of less than 6 months
• People whose wound is infected, has surrounding skin infection (cellulitis), or requires antibiotic tablets or injections
• People whose wound exposes tendon or bone
• People who have a bone infection (osteomyelitis) related to the wound
• People who are taking immune-suppressing medications, including steroid tablets at doses above 10 mg of prednisone per day, chemotherapy drugs, or other medications the study doctor believes may slow wound healing (such as certain biologics)
• People who have applied steroid creams or ointments directly to the wound within the past month
• People whose blood sugar control measure (HbA1c) was 12% or higher within the past 3 months
• People whose wound has already shrunk by more than 20% in the 2 weeks before the screening visit
• People whose wound shrinks by 20% or more during the 2-week screening period
• Women who are pregnant or planning to become pregnant within the next 6 months
• People who have end-stage kidney disease requiring dialysis
• People who have taken part in another clinical trial using an experimental treatment within the past 30 days
• People who, in the study doctor's opinion, have a medical or psychological condition that could affect study results
• People who have received hyperbaric oxygen therapy or a specialised wound product (called a CAMP) within the past 30 days
• People who score below 17 on a standard malnutrition screening tool called the Mini Nutritional Assessment
• People whose wound has an active or hidden (latent) infection
• People who have a medical condition that the study team determines would create an unacceptable risk of complications (confirm with trial site)

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