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Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)

Testing how well Artacent® works for healing.

Recruiting
18 years and older
All
Phase 4

Chronic Diabetic Foot Ulcers (DFUs) are painful sores on the feet of people with diabetes. They can take a long time to heal and can lead to serious problems like infections or even amputations if not treated properly. This study is looking at how well a special treatment, called Dual Layer Amniotic Membrane (DLAM), works for healing these ulcers. The DLAM is made from amniotic membranes, which are tissues that help babies grow in the womb. These tissues have special growth factors that can help heal wounds.

The study will compare the DLAM treatment combined with standard care against standard care alone. It will take 12 months to complete and involves weekly visits. If you join, you must be at least 18 years old, have diabetes, and meet certain ulcer requirements. You cannot participate if your ulcer is infected, if you have a life expectancy under six months, or if you have certain other health issues.

  • The study lasts 12 months and includes weekly visits.
  • You will receive either DLAM treatment and standard care or just standard care.
  • Participation is only for those meeting specific health criteria.
Study details
    Chronic Diabetic Foot Ulcers

NCT04457752

SerenaGroup, Inc.

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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