Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
NCT07620379
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
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
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT07620379