Using light therapy to improve healing of diabetic foot ulcers
Action of Photodynamic Therapy on Wound Quality and Tissue Repair in the Diabetic Foot: Double Blind Randomized Controlled Clinical Study
This study is testing if adding light therapy to regular treatment can help people with diabetic foot ulcers heal better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Nove de Julho Academic / other |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT06416462 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of antimicrobial photodynamic therapy (aPDT) on the healing quality of diabetic foot ulcers. It involves a randomized, controlled, double-blind design where participants are divided into two groups: one receiving standard care plus aPDT and the other receiving standard care with a simulated treatment. The study aims to assess wound quality and tissue repair using the Bates-Jensen scale over a series of treatment sessions. Conducted in a Municipal Health Center in Rio de Janeiro, the research seeks to provide stronger evidence for the effectiveness of aPDT in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic neuropathic diabetic foot wounds that are contaminated and meet specific criteria on the Bates-Jensen scale.
Not a fit: Patients with diabetic foot ulcers of non-neuropathic origin or those with ischemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the healing process and quality of life for patients suffering from diabetic foot ulcers.
How similar studies have performed: While there is some evidence supporting the use of aPDT for wound healing, this specific approach is still under investigation and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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%.
Where this trial is running
São Paulo, SP
- Raquel Agnelli Mesquita-Ferrari — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Study coordinator: Raquel Agnelli Mesquita-Ferrari, PhD
- Email: raquel.mesquita@gmail.com
- Phone: +55 (11) 2633-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.