Materials to Spread Pressure in Diabetic Foot Ulcers
Official title: Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
Run by University of Valencia · NCT07620379 · Data updated 2026-11-12
A test to see if pressure-distributing materials like felt padding help heal neuropathic foot ulcers in people with diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 75 Years |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Status | Recruiting |
| Started | March 9, 2021 |
| Main results expected | January 1, 2027 |
| Study ends | March 8, 2027 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07620379 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 55-75 with diabetes, adequate ankle–brachial index (0.8–1.2), and no active foot injuries preventing participation.
✕Probably not a fit
Individuals with non-vascular foot ulcers, severe comorbidities, or allergies to study materials may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project explores how different pressure-distribution materials affect tissue response and sole pressure in diabetic patients. The study has two phases: first, evaluating material biomechanics in volunteers without ulcers; second, applying the chosen materials to patients with revascularized neuropathic ulcers to see which works best for healing. The focus is on reducing plantar pressure and improving healing of neuropathic ulcers using felt padding and related materials. Participants are adults aged 55 to 75 with diabetes and specific vascular criteria, monitored across a single center in Valencia, Spain. The study will measure tissue response, pressure changes, and healing outcomes over the treatment period.
Why it matters
Potential benefit: If successful, patients may experience faster healing of neuropathic foot ulcers and reduced risk of pressure-related complications.
How similar studies have gone: Prior work has shown that pressure-distributing materials can reduce plantar pressure and support healing in diabetic feet, though results vary by material.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain Recruiting
Study contacts
- Study coordinator: IVAN JULIAN ROCHINA, PhD
- Email: ivan.julian@uv.es
- Phone: +34 639687251
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.