Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for people with hard-to-heal diabetic foot ulcers or venous leg ulcers. It studies the EPIFIX wound graft, made from dried human amnion/chorion membrane (layers of the birth sac).

Nem

All sexes can join.

A betegség stádiuma

Diabetic foot ulcer or venous leg ulcer that has not shrunk in area by at least 50% after 4 weeks of usual treatment.

Korábbi kezelés

At least 4 weeks of usual wound care, such as removing dead tissue, infection control, wound cleaning, blood sugar control for diabetic foot ulcers, compression for venous ulcers, and moist wound dressings.

A részvétel fő kizáró okai

• Active or hidden infection in the wound area.
• Conditions that make problems after the procedure too risky.
• Ulcers that cannot be cleaned of dead tissue well enough, or where poor blood flow lets the wound bed die early after cleaning.
• Several ulcer areas with exposed bone and no blood flow in the wound bed.
• Allergy to the aminoglycoside antibiotics used in making the graft.

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

A vizsgálat csoportja

• Patients with Non-Ischemic Chronic WoundsA vizsgált kezelés

  Patients with intractable diabetic foot ulcer or venous leg ulcer that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies.

  Kezelés: EPIFIX