RecruitingNot Applicable

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

Spain46 participantsStarted 2021-03-09

Plain-language 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.

Who can participate

Age range

55 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Near-infrared perfusion index (NIR perfusion)

Timeframe: Baseline and 4 days

Trial details

NCT IDNCT07620379

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

IVAN JULIAN ROCHINA, PhD

+34 639687251 ivan.julian@uv.es

View on ClinicalTrials.gov More Diabetic Complications trials