Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers

Condition(s) studied

Investigational drug(s) / intervention(s)

felt padding: The 5 mm felt pad is applied for 4 days and then removed. After allowing the skin at least 48 hours to recover, the 10 mm felt pad is applied, also for 4 days.

Study summary

The hypothesis of this study is based on the premise that pressure-distributing materials with superior biomechanical and tissue response properties will be capable of improving the healing rate of neuropathic ulcers.

The overarching objective of the present project is to assess the influence of the nature and method of application of the materials under study on tissue response, the reduction of pressure on the sole of the foot, and the healing of neuropathic ulcers in patients with diabetes mellitus.

Eligibility

Primary outcome measure(s)

• Near-infrared perfusion index (NIR perfusion) — Baseline and 4 days
  Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany). This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm. The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds. Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.

Trial sites (1)

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