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Use of Laser and Antimicrobial Dyes in the treatment of infected ulcers in people with Diabetes Mellitus: a Randomized Clinical Trial

Photodynamic Therapy in the treatment of foot ulcers in people with Diabetes Mellitus: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2dm7t97
Enrollment
Unknown
Registered
2023-01-23
Start date
2023-05-22
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot ulcer

Interventions

In the present study, patients will be randomized into two groups, one intervention group, which will receive common treatment in association with Photodynamic Therapy, and another group that will rec
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Sponsors

Escola de Enfermagem de Ribeirão Preto - Universidade de São Paulo
Lead Sponsor
Escola de Enfermagem de Ribeirão Preto - Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older; Diagnosis of Diabetes (recorded in medical records or supporting test); have foot ulcers; agreeing to perform a biopsy of the lesion; being available to attend the outpatient clinic, on pre-established days, during six weeks of treatment + an additional week for evaluating the outcomes.

Exclusion criteria

Exclusion criteria: Patients using immunosuppressive drugs; diagnosis/treatment of neoplasms; Chronic Renal Failure; Peripheral Vascular Insufficiency; Suspected or confirmed osteomyelitis; lesion with an area larger than 10x12 centimeters.

Design outcomes

Primary

MeasureTime frame
It is expected to find a reduction in the types of bacteria, verified through the ulcer biopsy method.

Secondary

MeasureTime frame
It is expected to find a clinical evolution of the lesion, through the improvement of the aspects of the ulcer, verified through the qualitative description of the data related to the appearance of the tissue, exudate, edge, odor, and aspect of the perilesional skin.;It is expected to find a lower Ulcer Healing Index, verified through the reduction in the size of the ulcer, verified through the analysis of the size with the aid of a millimeter measuring tape.

Countries

Brazil

Contacts

Public ContactMaria Girlane Albuquerque

Escola de Enfermagem de Ribeirão Preto - Universidade de São Paulo

girlanealbuquerque@usp.br+55 (88) 998516914

Outcome results

None listed

Source: REBEC (via WHO ICTRP)