Sensor-Assisted Wound Therapy in Plantar Diabetic Foot Ulcer Treatment: A Randomized Clinical Trial

Area of Science:

• Biomedical Engineering
• Diabetic Foot Care
• Wound Healing Technology

Background:

• Plantar diabetic foot ulcers (DFUs) require offloading, which restricts mobility and can negatively impact patient well-being.
• Non-adherence to offloading protocols due to mobility limitations often delays DFU healing.
• Existing offloading methods can be cumbersome and may lead to patient non-compliance.

Purpose of the Study:

• To evaluate a novel sensor-assisted wound therapy system for treating plantar diabetic foot ulcers.
• To assess the impact of continuous monitoring and alerts on DFU healing rates and patient mobility.
• To compare the efficacy of non-removable offloading devices with integrated sensors against standard care.

Main Methods:

• Development of three non-removable offloading techniques (multilayer felt sole, felt-fiberglass sole, total contact casts) with integrated pressure, temperature, and humidity sensors.
• Implementation of a smartwatch and web application for real-time data display and alerts when pressure exceeds 125 kPa.
• A randomized clinical trial involving 20 ambulatory patients, comparing sensor-assisted therapy with a control group receiving standard offloading without data feedback.

Main Results:

• The intervention group demonstrated a significantly shorter median time to ulcer healing (40.5 days) compared to the control group (266.0 days) (P = .037).
• Increasing ulcer area was observed less frequently in the intervention group (7.9%) versus the control group (29.7%) (P = .033).
• Median time to 50% wound area reduction was faster in the intervention group (10.2 days) vs. control (19.1 days), though not statistically significant (P = .2).

Conclusions:

• Sensor-assisted wound therapy facilitates rapid closure of plantar diabetic foot ulcers.
• This approach allows patients to maintain mobility during ulcer treatment, mitigating associated complications.
• The technology shows promise for improving patient outcomes and adherence in diabetic foot ulcer management.