Search / Trial NCT06236750

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

Launched by MIMEDX GROUP, INC. · Jan 24, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Description

The study will enroll 75 subjects diagnosed with intractable diabetic foot ulcers or venous leg ulcers at 5 plastic surgery sites in Japan. Subjects will be treated with weekly applications of EPIFIX for up to 12 weeks, followed by 6 months of follow-up.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with intractable diabetic foot ulcers or venous leg ulcers that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies, such as radical wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), glycemic control for diabetic foot ulcers, compression therapy for venous stasis ulcers and moist therapy using wound dressing materials.
  • Exclusion Criteria:
  • 1. Areas of active infection or latent infection.
  • 2. Patients with disorders that would cause an intolerable risk of postoperative complications.
  • 3. Ulcers that cannot be sufficiently debrided.
  • 4. Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage.
  • 5. Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed.
  • 6. Patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.

About Mimedx Group, Inc.

Mimedx Group, Inc. is a leading biotechnology company focused on the development and commercialization of innovative regenerative medicine products, particularly in the field of wound care and orthopedic applications. With a commitment to advancing patient care, Mimedx leverages its expertise in placental tissue-based therapies to address unmet medical needs, aiming to enhance healing outcomes and improve quality of life for patients. The company actively engages in clinical trials to validate the efficacy and safety of its products, contributing to the growing body of evidence supporting the use of regenerative medicine in clinical practice. Through its dedication to research and development, Mimedx is positioned at the forefront of transforming traditional treatment paradigms.

Locations

Shinjuku Ku, Tokyo, Japan

Mitaka Shi, Tokyo, Japan

Kobe Shi, Hyogo, Japan

Bunkyō Ku, Tokyo, Japan

Iruma Gun, Saitama, Japan

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0