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The use of lasers with antimicrobial drugs to treat infected wounds in people with diabetes: randomized clinical trial

Laserterapy associated with photodynamic therapy in the treatment of infected wounds in persons with diabetes: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-23p4zr
Enrollment
Unknown
Registered
2020-03-26
Start date
2020-05-01
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

Diabetes mellitus

Interventions

Experimental group: 19 people with diabetes mellitus and diabetic foot who will receive methylene blue laser therapy, followed up weekly for a period of six weeks. Control group: 19 people with diabe
Device
E02.594

Sponsors

Maria Girlane Sousa Albuquerque Brandão
Lead Sponsor
Universidade Internacional da Integração da Lusofonia Afro-Brasileira
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Individuals aged 18 years or over; being diabetic and presenting an infected wound (evaluation of the wound will be carried out by analyzing clinical signs: presence of odor, exudate, discoloration of the tissues inside and margins of the wound, edema, friable and hemorrhagic granulation tissue); attend the clinic on pre-established days.

Exclusion criteria

Exclusion criteria: Suspected or confirmed pregnancy; use immunosuppressive drugs; being on antibiotics or having finished treatment less than 30 days; use of any topical medication on the wound for less than seven days; diagnosis / Treatment of Carcinoma; presenting a wound with an area greater than 144 cm2; anemia (Hb less than 12 g / dL); Chronic Kidney Failure; osteomyelitis; being under the influence of alcohol or psychotropic substances; chronic malnutrition; peripheral vascular insufficiency.

Design outcomes

Secondary

MeasureTime frame
It is expected to find a reduction in the lesion area, through the use of methylene blue laser therapy, using the analysis of the process in tissue repair using the PUSH scale. We will observe throughout the treatment, the reduction of the lesion area, exudate and granulation tissue, before, during and after the treatment.—

Primary

MeasureTime frame
It is expected to find a reduction in the infectious infiltrate, through the use of methylene blue laser therapy, using the microbiological analysis of the lesion. We will observe throughout the treatment, the microbiological load before, during and after the treatment.—

Countries

Brazil

Contacts

Public ContactMaria Girlane Sousa Brandão

Universidade da Integração da Lusofonia AfroBrasileira

girlane.albuquerque@yahoo.com.br+55 88998516914

Outcome results

None listed

Source: REBEC (via WHO ICTRP)