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Use of Low Power Laser in wound healing in Diabetic foot: Randomized clinical trial

Photobiomodulation in foot ulcer tissue repair Diabetic: Randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3v7mrsq
Enrollment
Unknown
Registered
2022-03-23
Start date
2022-03-05
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

Patients who meet the eligibility criteria will be included in the study, and will be randomized into two groups: intervention group (ILIB GROUP) who will undergo the application of ILIB therapy trans
E02.594.540

Sponsors

Universidade Federal do Maranhão
Lead Sponsor
Universidade Federal do Maranhão
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Will be included in this study volunteers who complete the following criteria:Be 18 years of age or older; Present a clinical diagnosis of type II diabetes; Being monitored at the outpatient clinic of the HMI vascular clinic; Present ulcer located in the region of the feet, medial and distal third of the leg, classified in grade 1 and 2 of stage A, by the System of The University of Texas Diabetic Wound Classification of Texas Diabetic Wound Classification System); Ulcers with a length between 1 to 5 cm; Ulcer with onset time less than or equal to 3 months; Have preserved cognitive ability, assessed with the help of the mini exam of mental state (MMSE)

Exclusion criteria

Exclusion criteria: The exclusion criteria established were: Uncontrolled diabetes, measured at the time of recruitment or via information obtained from the medical record; Smoker; Alcoholic; Neuromuscular or musculoskeletal disorders; Peripheral arterial disease (PAOD), determined by measuring the ankle-arm index (ABI) less than 0.90; Conditions that contraindicate Photobiomodulation.

Design outcomes

Primary

MeasureTime frame
It is expected to find the ulcer healing rate, verified by the computerized planimetry method, and presentation of the parameters in percentages, used to verify if the outcome really occurred

Secondary

MeasureTime frame
it is expected to evaluate the clinical evolution of the ulcer, through 28 indicators of the results referring to wound healing: second intention (1103) and tissue integrity: skin and mucous membranes (1101) of the Nursing Outcomes Classification (NOC). The NOC results are composed of indicators that have five-point Likert scales to assess state variability.

Countries

Brazil

Contacts

Public ContactHospital universitário / HU - UFMA

Universidade Federal do Maranhão

cep@huufma.br+55(98)2109-1250

Outcome results

None listed

Source: REBEC (via WHO ICTRP)