A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

Launched by ORGANOGENESIS · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for diabetic foot ulcers, which are wounds on the feet that don’t heal well in people with diabetes. Researchers want to see if a special type of collagen, combined with an antimicrobial agent (which helps fight infection), works better than standard treatment alone for healing these chronic wounds. The trial is currently recruiting participants who are at least 18 years old and have been diagnosed with type 1 or type 2 diabetes. Eligible participants should have a specific type of foot ulcer that has been present for at least four weeks and meets certain size and location criteria.

If you join the study, you would receive either the new collagen treatment along with standard care or standard care alone, and you'll be closely monitored by the research team. Participants will need to visit the clinic weekly for assessments and must agree to follow specific guidelines for offloading their ulcer (which means keeping pressure off the affected area to help it heal). It’s important to note that certain health conditions and treatments may disqualify someone from participating, such as recent infections, serious medical issues, or specific medications. This trial aims to find better ways to help improve healing for those struggling with diabetic foot ulcers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years of age or older.
• • 2. Diagnosis of type 1 or 2 Diabetes mellitus.
• • 3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2
• • 4. The target ulcer must have been present for a minimum of 4 weeks
• • 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
• • 6. The target ulcer must be Wagner 1 or 2 grade
• • 7. The affected limb must have adequate perfusion confirmed by vascular assessment.
• • 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
• • 9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
• • 10. The potential subject must consent to using the prescribed offloading method for the duration of the study.
• • 11. The potential subject must agree to attend the weekly study visits required by the protocol.
• • 12. The potential subject must be willing and able to participate in the informed consent process.
• Exclusion Criteria:
• • 1. The potential subject is known to have a life expectancy of \< 6 months.
• • 2. The potential subject's target ulcer is not secondary to diabetes.
• • 3. The target ulcer is infected or there is cellulitis in the surrounding skin.
• • 4. The target ulcer exposes tendon or bone.
• • 5. There is evidence of osteomyelitis
• • 6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• • 7. The potential subject is receiving immunosuppressants or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing.
• • 8. The potential subject is taking hydroxyurea.
• • 9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• • 10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
• • 11. The potential subject has a controlled glycated hemoglobin (HbA1c) within 3 months of the initial screening visit.
• • 12. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
• • 13. Women who are pregnant or considering becoming pregnant within the next 6 months.
• • 14. The potential subject has end stage renal disease requiring dialysis.
• • 15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
• • 16. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
• • 17. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
• • 18. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.