Clinical trial NCT03250533: Analysis of the Effects of LED Phototherapy and Electrical Stimulation in the Healing of Diabetic Ulcers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcer
Diabetes Mellitus
Keywords: Wound healing
Phototherapy
Electrotherapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of ulcer healing - Digital photography
timeFrame: Twelve weeks
Secondary outcomes:
measure: Infrared thermography
timeFrame: Twelve weeks
measure: Numerical pain scale
timeFrame: Twelve weeks
measure: Von frey digital analgesiometer
timeFrame: Twelve weeks
measure: Digital Durometer
timeFrame: Twelve weeks
measure: Infrared Plethysmography
timeFrame: Twelve weeks
measure: Bioimpedance
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rinaldo Guirro, PhD
role: PRINCIPAL_INVESTIGATOR
References: