Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

October 3, 2022

Primary Completion Date

March 30, 2025

Study Completion Date

April 30, 2025

Conditions
Foot Ulcer, Diabetic
Interventions
COMBINATION_PRODUCT

DERMASEAL

a novel skin substitute formulated as planar, thin film

BIOLOGICAL

Plasma Film

a planar, thin film made from human plasma

OTHER

Standard of Care

standard procedures for managing diabetic foot ulcers including debridement of unhealthy tissue and maintenance of a moist wound environment

Trial Locations (4)

33143

Doctors Research Network, South Miami

44512

Lower Extremity Institute for Research and Therapy, LLC, Boardman

78501

Futuro Clinical Trials, LLC, McAllen

93710

Limb Preservation Platform, Inc., Fresno

All Listed Sponsors
lead

Vitruvian Medical Devices, Inc.

INDUSTRY