Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 28, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
Non-infected Diabetic Foot UlcerDiabetic FootDiabetic WoundDiabetic Foot UlcerNon-ischemic Diabetic Foot Ulcer
Interventions
OTHER

BR-AM

BR-AM is a single-layer amniotic membrane allograft. BR-AM 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 of care is defined as:~* Debridement,~* Wound cleansing with a neutral, non-irritating and non-toxic solution,~* Non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, a secondary retention bandage, and~* An off-loading device."

Trial Locations (17)

11042

RECRUITING

Site 16, Lake Success

27599

RECRUITING

Site 15, Chapel Hill

32720

RECRUITING

Site 28, DeLand

33134

RECRUITING

Site 27, Coral Gables

33442

RECRUITING

Site 20, Deerfield Beach

35976

RECRUITING

Site 17, Guntersville

48201

RECRUITING

Site 26, Detroit

62704

RECRUITING

Site 23, Springfield

76028

RECRUITING

Site 21, Burleson

78229

RECRUITING

Site 24, San Antonio

78520

RECRUITING

Site 29, Brownsville

85206

RECRUITING

Site 22, Mesa

85723

RECRUITING

Site 25, Tucson

92081

RECRUITING

Site 01, Vista

93551

RECRUITING

Site 19, Palmdale

94115

RECRUITING

Site 02, San Francisco

02118

RECRUITING

Site 18, Boston

Sponsors
All Listed Sponsors
lead

BioStem Technologies

INDUSTRY

NCT06565156 - Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM | Biotech Hunter | Biotech Hunter