Trials
Search / Trial NCT06416462

Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot

Launched by UNIVERSITY OF NOVE DE JULHO · May 14, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called antimicrobial photodynamic therapy (aPDT) to see how it helps improve the healing of diabetic foot ulcers. A diabetic foot ulcer is a sore that can develop in people with diabetes, and it affects about 10.5% of the population. This condition can make life difficult for patients and places a heavy burden on healthcare systems. The goal of this study is to gather more evidence about how effective aPDT is in healing these wounds and improving the overall quality of the tissue around them.

To participate in this trial, individuals must be between the ages of 65 and 74 and have chronic wounds caused by diabetic foot issues. Participants should have wounds that are contaminated and show a specific level of severity on a scale used to measure wound quality. Unfortunately, those with wounds from other causes, severe blood flow problems, or poorly controlled diabetes will not be eligible. If someone qualifies and joins the study, they can expect to receive aPDT treatment and be monitored for improvements in their wounds. This research aims to enhance the quality of life for those suffering from diabetic foot ulcers and provide clearer guidance on effective treatments.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • both sexes
  • chronic wounds originating from the neuropathic diabetic foot
  • contaminated lesions
  • total score obtained on the Bates-Jensen scale between 13 and 60
  • who submits all requested exams
  • Exclusion Criteria:
  • wounds with etiologies that are not related to the diabetic foot
  • ischemic diabetic foot who has an ankle-brachial index with a value between 0.7 and 1.3.
  • glycated hemoglobin greater than 8%.

Trial Officials

Raquel Agnelli Mesquita-Ferrari, PhD

Study Director

University of Nove de Julho

About University Of Nove De Julho

The University of Nove de Julho (UNINOVE) is a prestigious educational institution located in São Paulo, Brazil, renowned for its commitment to advancing research and innovation in the field of health sciences. As a clinical trial sponsor, UNINOVE aims to foster collaboration between academia and the healthcare industry, facilitating the development and evaluation of novel therapeutic interventions. With a robust infrastructure and a team of experienced researchers, the university is dedicated to conducting high-quality clinical trials that adhere to rigorous ethical standards and regulatory guidelines, ultimately contributing to improved health outcomes and the enhancement of medical knowledge.

Locations

São Paulo, Sp, Brazil

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0