Type 1 Diabetes Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older.
- You have been diagnosed with type 1 or type 2 diabetes.
- Your wound (ulcer) measures at least 1.0 cm² in size at the time of joining.
- Your wound has been present for at least 4 weeks.
- Your wound is on your foot, with most of it located below the ankle bone.
- Your wound is classified as Wagner grade 1 or 2, meaning it is not too deep (confirm with trial site).
- Blood flow to the affected leg and foot has been checked and confirmed to be adequate.
- If you have more than one wound, they must be at least 2 cm apart from each other.
- If your wound is on the bottom of your foot, you must have been using a pressure-relieving method (such as a special boot or cast) for at least 14 days before joining.
- You agree to use the pressure-relieving method recommended by the study team for the entire duration of the trial.
- You agree to attend weekly check-up visits as required by the study.
- You are willing and able to read and sign a consent form to participate.
Who may not be able to join:
- Your life expectancy is estimated to be less than 6 months.
- Your wound is not caused by diabetes.
- Your wound is currently infected, or the skin around it is infected (cellulitis).
- Your wound is so deep that it exposes a tendon or bone.
- There are signs of bone infection (osteomyelitis) in or around the wound.
- You have an infection in the wound or elsewhere in your body that requires antibiotic tablets or injections.
- You are taking medications that suppress your immune system or chemotherapy drugs that may slow wound healing.
- You are currently taking a medication called hydroxyurea.
- You have applied steroid creams directly to the wound within the past month.
- You have had a partial amputation on the affected foot that makes it difficult to properly relieve pressure on the wound.
- Your HbA1c (a blood test measuring average blood sugar levels) result from the past 3 months does not meet the study's requirements (confirm with trial site).
- You have an active or inactive Charcot foot condition that makes it difficult to properly relieve pressure on the wound.
- You are pregnant or planning to become pregnant within the next 6 months.
- You have end-stage kidney disease and require dialysis.
- You have taken part in another clinical trial using an experimental treatment within the past 30 days.
- In the opinion of the study doctor, you have a medical or psychological condition that could affect how well the study can be carried out.
- You have received hyperbaric oxygen therapy or a special wound-healing skin product within the 30 days before your first screening visit.
- Your nutritional assessment score falls below a certain level, indicating significant malnutrition (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Maribel Henao, Organogenesis
Phone: (781) 575-0775
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closure
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.