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

Recruiting now · Not applicable

Conditions studied: Diabetic Complications, Foot Care

In brief

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.

Key facts

Study ID

NCT07620379

Run by

University of Valencia

People needed

46

Starts

2021-03-09

Expected to finish

2027-03-08

Last updated by the study team

2026-06-02

Who can join

Age: 55 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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