The US Food and Drug Administration has approved the INTEGRA DERMAL REGENERATION TEMPLATE for the additional indication of the treatment of non healing diabetic foot ulcers.
The device, an advanced three-dimensional porous matrix, designed to provide immediate wound closure and permanent regeneration of the dermis contains:
- cow collagen
- shark cartilage
The new approval is for the treatment of certain diabetic foot ulcers lasting longer than 6weeks that do not involve the exposure of a joint capsule, tendon, or bone. It is placed in direct contact the excised wound and acts as a scaffold for cell migration, allowing for regeneration of the dermal layer of the patient’s skin.
REFERENCE: FOOT ULCERS NEW DERMAL REPLACEMENT (FOUNDER) STUDY.