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

NARecruitingINTERVENTIONAL
Enrollment

177

Participants

Timeline

Start Date

December 20, 2024

Primary Completion Date

November 22, 2026

Study Completion Date

January 22, 2027

Conditions
Pathologic ProcessesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseaseDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesDiabetes ComplicationsDiabetic NeuropathiesFoot DiseasesDiabetic FootFoot UlcerDiabetes Mellitus, Type 2UlcerFoot 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.

Trial Locations (1)

70001

RECRUITING

Poirot Podiatry, Metairie

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

SerenaGroup, Inc.

NETWORK

lead

C5 Biomedical

INDUSTRY