RecruitingPhase 4NCT07364630

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.

Sponsor

BioLab Holdings

Enrollment

50 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

Venous Ulcer Diabetic Foot Ulcer Ulcer Ulcer Foot DFU Venous Leg Ulcer Venous Leg Ulcer (VLU)Foot Ulcer Chronic 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Membrane Wrap-Hydro™ DFU, Membrane Wrap-Hydro™ VLU, and others for people with dfu, diabetic foot ulcer, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTri-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.

OTHERMembrane 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.

OTHERMembrane 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.

OTHERMembrane 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.

OTHERTri-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.

OTHERMembrane 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.

OTHERMembrane 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.

OTHERMembrane 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.