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

Diabetes Mellitus Clinical Trial

Official title:

Analysis of the Effects of Phototherapy With Light-emitting Diodes (LED) and Electrical Stimulation in the Healing of Ulcers of Lower Diabetic Limbs: a Blind Controlled Randomized Clinical Test

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03250533
• Other study ID #: U1111-1143-0079
• Status: Not yet recruiting
• Phase: N/A
• First received: August 10, 2017
• Last updated: August 16, 2017
• Start date: September 1, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2017
• Source: University of Sao Paulo
• Contact: Rinaldo Guirro, PhD
• Phone: +551633154584
• Email: rguirro[@]fmrp.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Ulcer

Intervention

Device:
• Light emitting diodes (LED)
The light-emitting diode (LED) device consists of a soft 15 x 15 cm blanket, which allows the body segment curvature of the cutaneous lesion to be monitored. The LEDs are fixed equidistant to obtain uniform irradiation over the entire ulcer. The wound site will be surrounded by a PVC film (polyvinyl chloride), to avoid contamination, for posterior positioning of the LED device, applying light directly and perpendicularly, with energy density of 6 J / cm². All LEDs will be calibrated prior to the start of applications in the Laboratory of Photobiophysics of the Faculty of Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density.
• Fixed diphasic current
The electrical stimulation treatment will be performed with the fixed diphasic current of the Dualpex 071 equipment (Quark®, Piracicaba, SP, Brazil), with the monopolar technique, 100 Hz, maximum intensity of 1 mA / cm² of lesion for 10 minutes. Autoclave sterilized aluminum electrodes will be used, one on the lesion (negative pole) and the other transversal to the segment (positive pole). The size of the electrode will be proportional to the extension of the lesion, having as a means of contact between the electrode and the ulcer, sterile gauze moistened with 0.9% saline solution.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ulcer healing - Digital photography	Percentage (%)	Twelve weeks
Secondary	Infrared thermography	Skin temperature (Celsius Degree)	Twelve weeks
Secondary	Numerical pain scale	Intensity of pain (numerical scale)	Twelve weeks
Secondary	Von frey digital analgesiometer	Quantify the sensitivity	Twelve weeks
Secondary	Digital Durometer	Analyze the tissue firmness (Shore)	Twelve weeks
Secondary	Infrared Plethysmography	Changes in microvascular blood volume (mL/s)	Twelve weeks
Secondary	Bioimpedance	Phase angle (KHz)	Twelve weeks