Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)

PHASE4RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 3, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

October 31, 2026

Conditions
Diabetic Foot Ulcer
Interventions
OTHER

Amnion-Intermediate-Chorion

Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.

PROCEDURE

Standard of Care (SOC)

Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.

Trial Locations (8)

18104

RECRUITING

008, Allentown

19146

RECRUITING

004, Philadelphia

27804

RECRUITING

002, Rocky Mount

28117

RECRUITING

007, Mooresville

29926

ACTIVE_NOT_RECRUITING

006, Hilton Head Island

32216

RECRUITING

001, Jacksonville

60611

RECRUITING

003, Chicago

95403

RECRUITING

005, Santa Rosa

Sponsors
All Listed Sponsors
lead

Cellution Biologics

INDUSTRY

NCT07014176 - Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC) | Biotech Hunter | Biotech Hunter