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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Placental Membrane
Biological/VaccineDehyrdated Placental Membrane
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Placental Membrane DressingExperimental treatment 1 intervention
Group B: Historical ControlsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Wound Closure
Proportion of subjects achieving ≥90% wound closure.
Time frame
12 weeksSecondary outcomes
1
Time to wound closure
Time in number of days to ≥90% wound closure over the 12- week treatment period, starting from baseline to the time of initial observation of wound closure
Time frame
12 weeks2
Percent Change
Percent change from baseline in wound surface area (cm2)
Time frame
12 weeks Source ClinicalTrials.gov