Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellution Biologics

About this trial

The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.

Eligibility criteria

Qualifiers

18 years of age or older.

Diagnosis of type 1 or 2 Diabetes mellitus.

Hemoglobin A1c (HbA1c) level is < 12% (108 mmol/mol).

Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.

Disqualifiers

Subject must consent to using the prescribed off-loading method for the duration of the study.

Subject must agree to attend study visits required by the protocol.

Subject must be willing and able to participate in the informed consent process.

Known life expectancy of < 6 months.

Trial design

Treatments tested in this trial

  • Amnion-Intermediate-Chorion
  • Standard of Care (SOC)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators