Efficacy of Human Placental Graft in Diabetic Foot Ulcers

A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers

To determine the efficacy of full-thickness placental allograft in chronic wound healing

To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment

Inclusion Criteria:

• Male and female patients
• 18-80 years old
• Diagnosis of Type 1 or 2 Diabetes Mellitus
• Foot ulcers >1cm2 and <25cm2 for 4 weeks or more prior to enrollment
• Able to give consent to participate
• Compliance with all aspects of protocol and follow-up

Exclusion Criteria:

• Male and female patients younger than 18 years old
• Male or female patients older than 80 years old
• Smoking, and any additional health risk factors contraindicated with Revita use
• Involvement in any other ongoing studies