Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45-85
SponsorBioXTek
About this trial
Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Eligibility criteria
Qualifiers
Patient has signed the informed consent form.
Male or female patient at least 18 years of age or older, as of the date of the screening visit.
Confirmed diagnosis of Type 1 or Type 2 DM.
Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device.
Disqualifiers
Hemoglobin A1c (HbA1c) level is > 10%.
Chronic oral steroid use of > 7.5 mg daily within the previous 30 days preceding screening.
Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
Trial design
Treatments tested in this trial
- Placental Membrane
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
2Axsendo85024, PhoenixArizona, United States
Axsendo Clinical Research77058, HoustonTexas, United States
Sponsors and collaborators
BioXTek
Lead sponsor
Source ClinicalTrials.gov