Health Trials

Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

ConditionsPathologic ProcessesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseaseDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesDiabetes ComplicationsDiabetic NeuropathiesFoot DiseasesDiabetic FootFoot UlcerDiabetes Mellitus, Type 2UlcerFoot Ulcer Unhealed
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorC5 Biomedical

About this trial

The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.

Eligibility criteria

Qualifiers

At least 18 years of age or older.

Must have diagnosis of type 1 or 2 Diabetes mellitus.

At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.

Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.

Disqualifiers

Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.

Subject must consent to using the prescribed offloading method for the duration of the study.

Subject must agree to attend weekly study visits.

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

Trial design

Treatments tested in this trial

  • Standard of Care - DFU
  • AM/Single - DFU
  • AM/Double - DFU
  • Standard of Care - VLU
  • AM/Single - VLU
  • AM/Double - VLU

Treatment groups

177 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

C5 Biomedical

Lead sponsor

SerenaGroup, Inc.

Collaborator

Source ClinicalTrials.gov