Summary:
Patientcare Clinical Research LLC is conducting a clinical research study for individuals with diabetic foot ulcers to evaluate the safety and effectiveness of an investigational treatment, MDI-1228-mesylate Gel, used alongside standard wound care. This 12-week study aims to determine whether adding the investigational gel can improve complete wound healing compared to standard care alone. Eligible participants will receive close medical supervision at no cost and may gain access to a promising new treatment option. If you or someone you know has a non-healing diabetic foot ulcer, you may qualify to participate. Contact Patientcare Clinical Research LLC to learn more about enrollment.
Qualified Participants Must:
• Have diabetes with HbA1c ≤12 or well controlled on medication
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Be between 18 and 75 years old (male or female)
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Have at least one diabetic foot ulcer present for 6 weeks or longer and treated with standard care for at least 4 weeks
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Have a Wagner grade 2 ulcer located on the foot (top or bottom) or below the knee, without systemic infection
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Have an ulcer size less than 25 cm², with adequate spacing from other ulcers
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Have good blood flow to the affected limb (as confirmed by vascular testing)
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Have no active systemic infection
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Be willing and able to attend all study visits, follow study procedures, and provide written informed consent
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Agree to use effective contraception during the study and for 3 months after the last dose (if of child-bearing potential)