Diabetic Foot Clinical Trials

In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers. Matrion is composed of placental membrane derived from donated human birth tissue containing both the innermost amniotic layer and the outermost chorionic layer, inclusive of the trophoblast layer. Matrion is minimally processed and disinfected using a proprietary decellularization technology and terminally sterilized that safely renders the placental membrane acellular and sterile for its intended surgical applications. Read Less

This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing. Read Less

More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR). Read Less