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

RECRUITINGN/ASponsored by University of Valencia
Actively Recruiting
PhaseN/A
SponsorUniversity of Valencia
Started2021-03-09
Est. completion2027-01-01
Eligibility
Age55 Years – 75 Years
Healthy vol.Accepted

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.

Eligibility

Age: 55 Years – 75 YearsHealthy volunteers accepted
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

Conditions3

DiabetesDiabetic ComplicationsFoot Care

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