MedTrace Logo

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

NCT07620379 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-06-02

No results posted yet for this study

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.

Conditions

  • Diabetic Complications
  • Foot Care

Interventions

OTHER

felt padding

The 5 mm felt pad is applied for 4 days and then removed. After allowing the skin at least 48 hours to recover, the 10 mm felt pad is applied, also for 4 days.

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria La Fe

    collaborator OTHER

  • University of Valencia

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2027-01-01
Completion
2027-03-08

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620379 on ClinicalTrials.gov