Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 14, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

October 31, 2026

Conditions
Non-infected Venous Leg UlcerVenous Leg UlcerVenous InsufficiencyVenous StasisVenous Reflux
Interventions
OTHER

BR-AC

BR-AC is an amnion layer, intermediate layer, and chorion layer placental membrane processed together with no separation of the layers. BR-AC is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method, which, briefly includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C, and electron beam sterilization.

OTHER

Standard Care

"Standard Care is defined as:~* Sharp debridement,~* Wound cleansing with a neutral, non-irritating and non-toxic solution,~* Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and~* The UrgoK2™ dual compression system providing around 40 mmHg."

Trial Locations (22)

11042

RECRUITING

Site 16, Lake Success

32547

RECRUITING

Site 33, Fort Walton Beach

33126

RECRUITING

Site 35, Miami

33134

RECRUITING

Site 27, Coral Gables

33180

RECRUITING

Site 34, Aventura

33189

RECRUITING

Site 31, Miami

33442

RECRUITING

Site 20, Deerfield Beach

35976

RECRUITING

Site 17, Guntersville

62269

RECRUITING

Site 06, O'Fallon

63128

NOT_YET_RECRUITING

Site 32, St Louis

76104

RECRUITING

Site 03, Fort Worth

90502

RECRUITING

Site 30, Torrance

91204

RECRUITING

Site 19b, Glendale

91342

RECRUITING

Site 04, Sylmar

92081

RECRUITING

Site 01, Vista

93030

RECRUITING

Site 36, Oxnard

93036

RECRUITING

Site 37, Oxnard

93551

RECRUITING

Site 19, Palmdale

94115

RECRUITING

Site 02, San Francisco

94117

RECRUITING

Site 2a, San Francisco

94546

RECRUITING

Site 2b, Castro Valley

02118

RECRUITING

Site 18, Boston

Sponsors
All Listed Sponsors
lead

BioStem Technologies

INDUSTRY

NCT06811909 - Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC | Biotech Hunter | Biotech Hunter