Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorUniversity of Valencia
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- felt padding
Treatment groups
46 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Valencia
Lead sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborator
Source ClinicalTrials.gov