A double-blind randomized clinical trial applied to lower limb diabetic ulcers using a combination of biomembrane derived from natural latex (Hevea Brasiliensis) and light emitting equipment

Not Applicable

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

• Registration Number: RBR-5hgxy8
• Lead Sponsor: Faculdade do Gama

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients aged between 18 years and 75 years;
with history of diabetes mellitus type I or II; to present a single type A1 or A2 diabetic foot ulcer (University of Texas classification, with indication of outpatient treatment, without infection and without indication of surgical debridement, with a history of diabetic foot ulcer of more than 6 weeks duration and less of 12 months, have no allergy to latex, intellectually fit, have a cell phone with the ability to take photographs and have the application WhatsApp

Exclusion Criteria

Diabetes mellitus uncontrolled with glycated Hb> 10 g / dl; irregular use of medication for the disease or even without regular medical follow-up; evidence of osteomyelitis or gangrene at either end; have lesions with excessive exudate; be an active smoker, regular user of alcoholic beverages and / or illicit drugs; another chronic disease that at the discretion of the investigator compromises the participation in the study; pregnant or lactating women or women of child-bearing age without adequate contraception; participation in another clinical study in less than 1 year (unless justified by the researcher)

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the time required to heal and the response of each wavelength applied in the diabetic foot ulcer with the combined use of biomembrane derived from the natural latex (Hevea brasiliensis) associated to the light emitting equipment of leds and the standard treatment with dressings containing calcium alginate or SUS silver foam

Secondary Outcome Measures

Name	Time	Method
Percentage of wounds that reach closure at the end of 90 days of treatment; percentage reduction of the wound area (cm2) in the treatment groups at the end of 90 days of treatment compared to the baseline; comparison of fibroblast cell proliferation at each dosage of the wavelength ranges from 450 to 636; Comparison of the percentage reduction of wound area for varied wavelength protocol to red protocol (636 nm) - previously studied by the research group (since 2013); evolution of comparative quality of life among the treatments proposed; evaluation of signs and symptoms of adverse events of the proposed treatments; Validation of the image processing protocol developed in comparison to the ImageJTM standard with the data collected; to obtain a mathematical representation of the healing process by means of modeling techniques with the data collected; evaluate the electrical impedance of healed skin by reading the galvanic resistance of the skin (GRS)