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

Not Applicable

Recruiting

• Conditions: Diabetic foot ulcer; C19.246

• Registration Number: RBR-2dm7t97
• Lead Sponsor: Escola de Enfermagem de Ribeirão Preto - Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-23
• Last Update Posted: 22 August 2023
• Study Completion: 2024-02-02

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find a reduction in the types of bacteria, verified through the ulcer biopsy method.

Secondary Outcome Measures

Name	Time	Method
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.