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

Summary

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.

Conditions

• Pathologic Processes
• Diabetes Mellitus
• Glucose Metabolism Disorders
• Metabolic Diseases
• Endocrine System Disease
• Diabetic Angiopathies
• Vascular Diseases
• Cardiovascular Diseases
• Leg Ulcer
• Skin Ulcer
• Skin Diseases
• Diabetes Complications
• Diabetic Neuropathies
• Foot Diseases
• Diabetic Foot
• Foot Ulcer
• Diabetes Mellitus, Type 2
• Ulcer
• Foot Ulcer Unhealed

Interventions

OTHER

Standard of Care - DFU

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

AM/Single - DFU

Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

AM/Double - DFU

Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Standard of Care - VLU

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

AM/Single - VLU

Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

AM/Double - VLU

Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Sponsors & Collaborators

• SerenaGroup, Inc.

  collaborator NETWORK

• C5 Biomedical

  lead INDUSTRY

Principal Investigators

• Thomas Serena, MD · SerenaGroup, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-20

Primary Completion

2026-11-22

Completion

2027-01-22

Countries

• United States

Study Locations