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Search / Trial NCT07123285

Effect of Photobiomodulation on Healing of Venous Leg Ulcers: A Double-Blind Randomized Study

Launched by UNIVERSITY OF NOVE DE JULHO · Aug 7, 2025

Trial Information

Current as of August 22, 2025

Not yet recruiting

Keywords

Venous Ulcers Varicose Ulcers Photobiomodulation Lasers Phototherapy Venous Leg Ulcer

ClinConnect Summary

This clinical trial is studying whether a special light therapy called photobiomodulation (PBM), when combined with standard compression treatment, can help heal venous leg ulcers—these are wounds on the lower legs caused by poor blood flow in the veins. The study will include 104 adults aged 18 to 85 who have had these ulcers for at least three weeks and live in or near Lençóis Paulista. People with ulcers caused by other problems, pregnant women, or those with serious artery disease in their legs cannot join.

If you take part, you will be randomly assigned to one of two groups: one will receive the real light therapy plus compression, and the other will get a fake (sham) light treatment plus compression. Treatments will happen twice a week for 16 weeks. Researchers will check how well the wounds heal, changes in size and pain, quality of life, and other health measures. The goal is to find out if adding this light therapy helps ulcers heal faster or better compared to compression alone. The study is not yet recruiting participants but aims to provide useful information for people living with these difficult-to-heal leg wounds.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients of both sexes;
  • Individuals with venous ulcers in the lower limbs for at least three weeks that have not healed;
  • Age between 18 and 85 years;
  • Residents of Lençóis Paulista or nearby regions.
  • Exclusion Criteria:
  • Patients with ulcers of non-venous etiology;
  • Pregnant women;
  • Presence of severe arterial disease in the lower limbs.

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

Lençóis Paulista, , Brazil

Patients applied

0 patients applied

Trial Officials

Anna C Ratto Tempestini Horliana, PhD

Study Director

University of Nove de Julho

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported