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:

• People who are 18 years of age or older.
• People who have a diabetic foot ulcer (a wound on the foot related to diabetes) that goes through the outer layers of skin, located below the ankle bone.
• People whose wound to be studied is the largest wound present if there are multiple similar wounds, and any other wounds on the same foot are at least 2 cm away from the main wound being studied.
• People whose main wound has been present for more than 4 weeks but less than 1 year at the time of agreeing to join the study.
• People whose wound measures between 1.0 cm² and 25 cm² in size at the start of the study.
• People who have had a blood flow test within the past 3 months showing adequate circulation to the affected foot (confirm with trial site for which specific test applies).
• People whose wound has had pressure relieved from it (for example, by special footwear or a cast) for at least 14 days before the first treatment visit.
• Women who are able to become pregnant must be willing to use an acceptable form of contraception throughout the study and agree to pregnancy testing.
• People who are willing and able to attend weekly clinic visits and follow the study requirements.
• People who have read and signed the study consent form approved by an ethics review board before any study procedures begin.

Who may not be able to join:

• People whose foot wound is believed by the study doctor to be caused by something other than diabetes.
• People whose wound is considered by the study doctor to be suspicious for cancer.
• People whose wound is currently infected.
• People who have taken immune-suppressing medications (including steroid tablets above a certain dose), chemotherapy, or steroid creams applied to the wound for more than two weeks within the month before the study starts, or who are expected to need these during the study.
• People who have taken part in another clinical trial or used an experimental treatment or device within 30 days before the study starts.
• People who have had radiation treatment at the wound site at any point in their life.
• People whose wound has been treated with, or will need to be treated with, therapies not allowed by the study.
• People who have a previous diagnosis of HIV or Hepatitis C.
• People who have health conditions or a known history of not following medical treatment that would make it difficult to complete the study.
• People who have a bone infection in the affected foot, confirmed by X-ray within 30 days before the first screening visit.
• People who are pregnant or breastfeeding.
• People whose diabetes is poorly controlled, shown by a blood sugar measurement (HbA1c) above 12.0% within the past 90 days.
• People with severe kidney disease, shown by a specific blood test result within the past 6 months (confirm with trial site for exact values).
• People with an active Charcot foot condition (a serious bone and joint problem related to diabetes) in the affected limb.
• People whose wound has already shrunk in size by 30% or more during the initial 14-day standard care period before the first treatment visit.

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