Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMiMedx Group, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
Areas of active infection or latent infection.
Patients with disorders that would cause an intolerable risk of postoperative complications.
Ulcers that cannot be sufficiently debrided.
Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage.
Trial design
Treatments tested in this trial
- EPIFIX
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
MiMedx Group, Inc.
Lead sponsor
CMIC Co, Ltd. Japan
Collaborator
Source ClinicalTrials.gov