Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 75
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Spain
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
IVAN JULIAN ROCHINA, PhD
ivan.julian@uv.es
+34 639687251
Time Frame
Start Date: 2021-03-09
Estimated Completion Date: 2027-03-08
Participants
Target number of participants: 46
Treatments
Experimental: felt padding
The 5 mm and 10 mm felt pads are applied for 4 days.
Related Therapeutic Areas
Sponsors
Collaborators: Instituto de Investigacion Sanitaria La Fe
Leads: University of Valencia