First In Human Feasibility Clinical Study Evaluating the Safety of the XPD System for Periosteal Distraction [PD] (ACTRN12625000159459)

Chronic, non-healing foot and leg ulcers are often a result of reduced blood flow due to Peripheral Artery Disease (PAD) or other ischemic (reduced blood flow) conditions in patients with chronic diseases, such as diabetes. These ulcers can compromise quality of life and increase the risk of serious infection and result in injury and death of the tissue. The XPD is a new device that is designed to stretch the soft tissue around the bone (called the periosteum) to trigger the body’s natural healing process. It moves in a slow, controlled way to support healing and new tissue growth.

Trial phase

Pilot

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

Prof Gerard Goh

Key inclusion data

Inclusions: Over 18 years old; A foot or ankle ulcer that has been present for over 30 days; Attended a foot or podiatric clinic for conservative management.
Exclusions: Hypersensitivity to nickel; Participants with end stage renal disease, receiving dialysis treatment.