A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

Summary

The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.

Conditions

• Diabetic Foot Ulcer
• Foot Ulcer Chronic
• DFU
• Ulcer Foot
• Venous Leg Ulcer (VLU)
• Venous Leg Ulcer
• Venous Ulcer
• Leg Ulcers
• Ulcer

Interventions

OTHER

Tri-Membrane Wrap™ DFU

Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Membrane Wrap™ DFU

Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Membrane Wrap-Lite™ DFU

Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Membrane Wrap-Hydro™ DFU

Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Tri-Membrane Wrap™ VLU

Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Membrane Wrap™ VLU

Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Membrane Wrap-Lite™ VLU

Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Membrane Wrap-Hydro™ VLU

Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Sponsors & Collaborators

• Serena Group

  collaborator OTHER

• BioLab Holdings

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-02

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• United States