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

NCT07620379 | Recruiting

• 1 other identifier: 2020-672-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Complications; Foot Care

Keywords

diabetic foot; plantar pressure; offloading; felt padding; hyperspectral imaging; thermography; pressure redistribution; ulcer prevention

Outcome Measures

Primary Outcomes (1)

• Near-infrared perfusion index (NIR perfusion)

  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.

  Baseline and 4 days

Secondary Outcomes (7)

• Thermography

  Baseline and 4 days

• Peak pressure (Pmax)

  Baseline and 4 days

• Tissue oxygen saturation (StO₂)

  Baseline and 4 days

• Tissue hemoglobin index (THI)

  Baseline and 4 days

• Tissue wáter index (TWI)

  Baseline and 4 days

Study Arms (1)

felt padding

EXPERIMENTAL

The 5 mm and 10 mm felt pads are applied for 4 days.

Other: felt padding

Interventions

felt padding OTHER

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.

felt padding

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 55 and 75.
• Diagnosis of diabetes mellitus.
• Patients with an ankle-brachial index of \>0.8 and \<1.2.
• Signature of the informed consent form

You may not qualify if:

• Leg or foot injuries or ulcers that cause pain and prevent normal movement in both lower limbs.
• Foot trauma within the last month.
• Inability to adhere to the full schedule of measurements required by the study.
• Participants who do not sign the informed consent form.
• Known contact dermatitis to any of the study materials

Sponsors & Collaborators

• University of Valencia: lead
• Instituto de Investigacion Sanitaria La Fe: collaborator

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Complications; Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies

Central Study Contacts

IVAN JULIAN ROCHINA, PhD

CONTACT

+34 639687251; ivan.julian@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 2, 2026
• Study Start: March 9, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 8, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)