Analysis of the Effects of LED Phototherapy and Electrical Stimulation in the Healing of Diabetic Ulcers

Not Applicable

• Conditions: Diabetes Mellitus; Ulcer
• Interventions: Device: Light emitting diodes (LED); Device: Fixed diphasic current

• Registration Number: NCT03250533
• Lead Sponsor: University of Sao Paulo

Brief Summary

One of the important complications of DM is the diabetic foot that may present ulcers, which result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to peripheral vascular disease considered the main causes. In this way, the ulcers of the lower extremities of diabetics, have a complex and long cicatrization process. Faced with this, the treatment of chronic wounds is challenging, the diversity of treatments is great, however the search for new modalities of effective therapeutic resources, scientifically proven and financially feasible, that are available and easily accessible for clinical practice is still desirable . The aim of this study was to evaluate the responses of phototherapy with light emitting diodes (LED) and electrical stimulation with the fixed diphasic current (DF) in ulcers of diabetic patients. Diabetic volunteers who present with chronic skin ulcers will also be randomized (n = 13) to: Treatment group with LED 620 nm, Treatment group with LED 940 nm, Treatment group with fixed diphasic current and Control group. Interventions will occur three times a week for 12 weeks and evaluations will occur on the 1st, 30th, 60th, and 90th day of the intervention, followed by follow-up after 30 days of treatment completion.

Detailed Description

Background: Diabetes mellitus (DM) is a chronic disease currently considered a worldwide epidemic and has become a major public health problem. One of the important complications of DM is the diabetic foot that may present ulcers, which result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to peripheral vascular disease considered the main causes. In this way, the ulcers of the lower extremities of diabetics, have a complex and long healing process, as they present a reduction in the angiogenic response and deficiency of growth factors, making difficult the action of conventional treatments. The treatment of chronic wounds is challenging, the diversity of treatments is great, however the search for new modalities of effective, scientifically proven and financially viable therapeutic resources that are available and readily accessible to clinical practice is still desirable. Objective: To evaluate the responses of phototherapy with light emitting diodes (LED) and electrical stimulation with the fixed diphasic current (DF) in diabetic patient ulcers. METHODS: Diabetic volunteers of both genders, aged 30 to 65 years, who present chronic skin ulcers grade I or II will also be randomized (n = 13) in: Treatment group with LED 620 nm (G-LED 620) , Treatment group with LED 940 nm (G-LED 940), Treatment group with fixed diphasic current (G-DF) and Control group (GC). Interventions will occur three times a week for 12 weeks. The evaluations will take place on the pre-intervention day 1, 30, 60 and 90 days, followed by follow-up after 30 days of the end of the treatment, through the following instruments: numerical scale of pain, digital photography, infrared thermography, digital analgesimeter, Digital durometer, infrared plethysmography and bioimpedance. Statistical analysis: To analyze the data, normality test will be used to verify the distribution of the data and adequate statistical test for the appropriate inter- and intragroup comparisons, being thus considered two factors in the comparisons, time and group. A significance level of 5% will be adopted.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21
• Study Start: 2017-09-01
• Primary Completion: 2020-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Age range from 30 to 65 years;
• Diabetic patients with neuropathic, ischemic or neuroischemic ulcers in the legs and / or feet;
• With a duration of 4 weeks or more;
• Being grade I and / or II lesions by the Meggitt-Wagner classification;
• Have a good degree of cognition evaluated by the Mini-Mental State Examination - MEEM (Brucki et al., 2003);
• Be under medical supervision and perform regular dressings and debridements of the wound.

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Exclusion Criteria

• Those presenting with an associated disease, such as renal, neurological, immunological, hematological or hepatic disease, which may interfere with evaluation and / or therapeutic procedures, and which are not related to diabetes;
• Malignancies (carcinomas);
• Use of medications that alter the healing process (corticosteroids, immunosuppressants, among others);
• Clinical signs of infection (sepsis), acute cellulitis, osteomyelitis or gangrene;
• Those who do not agree to sign the Free and Informed Consent Form;
• And who do not meet the inclusion criteria described.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LED 620 nm group (G-LED 620)	Light emitting diodes (LED)	The LED device in the red light spectrum, with a wavelength of 620 nm, will be applied over the full extent of the wound.
LED 940 nm group (G-LED 940)	Light emitting diodes (LED)	The LED device in the infrared light spectrum, with a wavelength of 940 nm, will be applied over the full extent of the wound.
Fixed diphasic current group (G-DF)	Fixed diphasic current	The electrical stimulation will be carried out with the fixed diphasic current of the Dualpex 071 equipment, being applied throughout the extension of the wound.

Primary Outcome Measures

Name	Time	Method
Rate of ulcer healing - Digital photography	Twelve weeks	Percentage (%)

Secondary Outcome Measures

Name	Time	Method
Digital Durometer	Twelve weeks	Analyze the tissue firmness (Shore)
Infrared thermography	Twelve weeks	Skin temperature (Celsius Degree)
Numerical pain scale	Twelve weeks	Intensity of pain (numerical scale)
Von frey digital analgesiometer	Twelve weeks	Quantify the sensitivity
Infrared Plethysmography	Twelve weeks	Changes in microvascular blood volume (mL/s)
Bioimpedance	Twelve weeks	Phase angle (KHz)

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil