Clinical study with the choice of patients who present wounds and the use of natural latex insole associated with light emitting circuit of leds for light therapy

Not Applicable

• Conditions: Diabetes Mellitus and Diabetic Foot; C18.452.394.750; C14.907.320.191

• Registration Number: RBR-2g27rd
• Lead Sponsor: Faculdade do Gama

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients intellectually fit, with diabetes mellitus and affected by foot ulcers of neuropathic origin. With or without clinical signs of infection and after completing and signing a consent form

Exclusion Criteria

Pregnant women; under 18 years or over 75 years of age; with history of alcohol or drug abuse; with symptoms and diagnoses of osteomyelitis, local tissue necrosis; with cognitive, neurological, or latex hypersensitivity

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of ulcer recovery through the measurement of initial and final area of the ulcer (square centimeters). An average healing process index of 76.9% was observed in Group I, in the Group II control group, mean value was 51.4%, and in the Group III group, with a mean healing process index of 80 %<br>

Secondary Outcome Measures

Name	Time	Method
<br>Evaluation of the quality of life and impact of the wound in the daily life of the patient through the parameters of limitation by physical aspects and limitation by emotional aspects. Functional capacity loss (67.7%), social impairment (66.6%), overall limitation (60%) and pain (53.4%)<br>Pain evaluation according to McGill's descriptors: throbbing (40%); heat / burn (26.7%); painful and heavy (33%)