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

RecruitingNAAges 55 Years - 75 YearsAllUniversity of Valencia
NCT07620379 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • felt padding
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Where

1 site
Hospital Universitario y Politécnico La Fe
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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