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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
EPIFIX
DeviceEPIFIX® is an allograft derived from dehydrated human amnion/chorion membrane. EPIFIX is a medical device in Japan (Generic name: Material using human amniotic membrane for promotion of tissue healing) for use on intractable ulcers that are non-responsive to existing therapies for the purpose of promoting wound healing.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Patients with Non-Ischemic Chronic WoundsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks
The percentage of patients to achieve wound closure at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, as a measure of healing rate.
Time frame
4 weeks, 8 weeks, and 12 weeks after initial application2
Safety Endpoint: Incidence of Adverse Events
Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.
Time frame
9 months after initial applicationOther outcomes
1
Efficacy Endpoint: Reduction in Wound Size at 4 Weeks, 8 Weeks, and 12 Weeks
Wound size will be measured at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, and the percent reduction of wound area will be calculated compared to baseline (week 0), as a measure of rate of wound closure.
Time frame
4 weeks, 8 weeks, and 12 weeks after initial application2
Efficacy Endpoint: Time to Complete Wound Healing during 12 Weeks of Application
The amount of time after initial DHACM application to achieve complete epithelialization of the wound.
Time frame
12 weeks after initial application3
Efficacy Endpoint: Wound Recurrence for 6 months after Wound Closure
The recurrence rate of healed ulcers will be monitored for 6 months after wound closure is achieved.
Time frame
6 months after wound closure4
Safety Endpoint: Incidence of Device Deficiencies
Incidence rate of device deficiencies, severity, and details in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.
Time frame
9 months after initial applicationSponsors and contacts
Click on the lead sponsor to view all of their trials.
MiMedx Group, Inc.
Lead sponsor
CMIC Co, Ltd. Japan
Collaborator
Source ClinicalTrials.gov