Comparison of the use of a Biodressing and Laser Therapy for the treatment of Diabetic Foot Wounds

Comparison between the use of a Biocuration and Low Intensity Laser Therapy in the treatment of Diabetic Foot Ulcers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-25ng5pt

Enrollment

Unknown

Registered

2023-12-27

Start date

2024-03-31

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

Interventions

This is an experimental, randomized, double-blind and controlled study. The sample size will be 102 participants.Volunteers will be randomized into three groups. A randomization list will be generated

10 J/cm2. The treatment will be carried out twice a week, with 20 sessions totaling 10 weeks. The volunteers will be instructed to use standard treatment on the days when the treatment will not be car

VS3.003.001.006

E02.594

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers of both sexes;aged over 18; with a clinical diagnosis of type 2 diabetes mellitus; diabetic ulcers located in the foot region;who agree to take part in the study by signing the Informed Consent Form (ICF)

Exclusion criteria

Exclusion criteria: Ulcers located in other regions of the body; who are unable to attend the treatment days proposed by the research; who are using other types of coverage for diabetic ulcers, which hinder the use of Laser and the identification of the results proposed by this research

Design outcomes

Primary

Measure	Time frame
The diabetic foot ulcers healing rate will be considered the primary outcome. After the functional assessment, the diabetic foot ulcers (DFU) will be located and the region will be measured with a paper ruler and photographed for later analysis using the ImageJ® program. They will be evaluated before treatment, after 5 and 10 weeks. The values obtained from the measurements will be compared within and between groups to identify the effect of the treatments.	—

Measure

Time frame

The diabetic foot ulcers healing rate will be considered the primary outcome. After the functional assessment, the diabetic foot ulcers (DFU) will be located and the region will be measured with a paper ruler and photographed for later analysis using the ImageJ® program. They will be evaluated before treatment, after 5 and 10 weeks. The values obtained from the measurements will be compared within and between groups to identify the effect of the treatments.

—

Secondary

Measure	Time frame
Secondary endpoints will be: blood glucose levels and lesion depth. The volunteers' blood glucose levels will be checked once a week throughout the treatment. The test will be carried out using an Accu-Check® Active glucometer and serum levels of glycated hemoglobin (HbA) will be checked at the Clinical Analysis Laboratory of the Federal University of the Delta do Parnaíba-UFDPar. The data will be analyzed to see if there is a correlation with diabetic foot ulcers (DFU) healing in the groups studied. The University of Texas Wound Classification System tool will be used to identify whether there has been a change in ulcer depth before treatment, after 5 and 10 weeks.	—

Measure

Time frame

Secondary endpoints will be: blood glucose levels and lesion depth. The volunteers' blood glucose levels will be checked once a week throughout the treatment. The test will be carried out using an Accu-Check® Active glucometer and serum levels of glycated hemoglobin (HbA) will be checked at the Clinical Analysis Laboratory of the Federal University of the Delta do Parnaíba-UFDPar. The data will be analyzed to see if there is a correlation with diabetic foot ulcers (DFU) healing in the groups studied. The University of Texas Wound Classification System tool will be used to identify whether there has been a change in ulcer depth before treatment, after 5 and 10 weeks.

—

Countries

Brazil

Contacts

Public ContactVinicius Cardoso

Universidade Federal do Delta do Parnaíba

vscfisio@ufdpar.edu.br+55 86 999852919

Outcome results

None listed

Source: REBEC (via WHO ICTRP)