Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover

Trial statusNot yet recruiting
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 venous leg ulcers.

Eligibility criteria

Qualifiers

18 years of age or older.

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

Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization.

Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit.

Disqualifiers

The participant must agree to attend the weekly study visits required by the protocol.

The participant must be willing and able to participate in the informed consent process

Known life expectancy of <6 months.

Target ulcer is infected or there is cellulitis in the surrounding skin.

Trial design

Treatments tested in this trial

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

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators