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

NCT03250533 | Unknown DMC

• 1 other identifier: U1111-1143-0079
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcer; Diabetes Mellitus

Keywords

Wound healing; Phototherapy; Electrotherapy

Outcome Measures

Primary Outcomes (1)

• Rate of ulcer healing - Digital photography

  Percentage (%)

  Twelve weeks

Secondary Outcomes (6)

• Infrared thermography

  Twelve weeks

• Numerical pain scale

  Twelve weeks

• Von frey digital analgesiometer

  Twelve weeks

• Digital Durometer

  Twelve weeks

• Infrared Plethysmography

  Twelve weeks

Study Arms (4)

LED 620 nm group (G-LED 620)

EXPERIMENTAL

The LED device in the red light spectrum, with a wavelength of 620 nm, will be applied over the full extent of the wound.

Device: Light emitting diodes (LED)

LED 940 nm group (G-LED 940)

EXPERIMENTAL

The LED device in the infrared light spectrum, with a wavelength of 940 nm, will be applied over the full extent of the wound.

Device: Light emitting diodes (LED)

Fixed diphasic current group (G-DF)

EXPERIMENTAL

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.

Device: Fixed diphasic current

Control group (G-C)

NO INTERVENTION

Volunteers from this group will not be submitted to treatment and will only be evaluated before, every 30 days, after the 12 week period and 30 days after the last evaluation. It is worth mentioning that, after the end of its participation, if the wound is not fully healed, the treatment will be offered with LED or diphasic current.

Interventions

Light emitting diodes (LED) DEVICE

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.

LED 620 nm group (G-LED 620); LED 940 nm group (G-LED 940)

Fixed diphasic current DEVICE

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.

Fixed diphasic current group (G-DF)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

• Borges NCS, Soares LR, Perissini MM, Carvalho MS, Guirro ECO, Freitas MCF, Guirro RRJ. Photobiomodulation using red and infrared spectrum light emitting-diode (LED) for the healing of diabetic foot ulcers: a controlled randomized clinical trial. Lasers Med Sci. 2024 Oct 9;39(1):253. doi: 10.1007/s10103-024-04199-5.

  PMID: 39382587 DERIVED

MeSH Terms

Conditions

Ulcer; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rinaldo Guirro, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinaldo Guirro, PhD

CONTACT

+551633154584; rguirro@fmrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PT, PhD

Model Details: Volunteers will also be randomized between groups: * LED treatment group 620 nm (G-LED 620; n = 13) * Treatment group with LED 940 nm (G-LED 940; n = 13) * Treatment group with fixed diphasic current (G-DF; n = 13) * Control group (G-C; n = 13)

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: September 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

BR (1)