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REOXCARE Dressing to Improve Healing in Diabetic Foot Ulcers (DFU)

NCT05413746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-29

No results posted yet for this study

Summary

It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on the severity of the injury and inversely to the mechanisms of physiological antioxidants of these patients. Therefore, these patients present a situation of oxidative stress (high lipid peroxidation), with an insufficient level of antioxidant enzymes to reverse this state, which leads to maintenance of the inflammatory situation and therefore the chronification of the ulcer. Investigators' aim in this study is to measure the benefits that the application of the product with antioxidant capacity REOXCARE can bring, together with the usual good clinical wound care guidelines and other essential therapeutic activities, such as pressure relief in the area of the ulcers.

Conditions

Interventions

DEVICE

Reoxcare antioxidant dressing

After wound cleaning activities, wound bed debridement if necessary and elimination of hyperkeratotic edges, wounds are treated with Reoxcare as primary dressing and the approppriate secondary dressing for adequate exudates management

Sponsors & Collaborators

  • Hospital de Cruces

    collaborator OTHER

  • Histocell, S.L.

    lead INDUSTRY

Principal Investigators

  • Andima Basterretxea, MD · Hospital Universitario de Cruces

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2020-03-17
Completion
2020-06-06

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT05413746 on ClinicalTrials.gov