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
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Rate of ulcer healing - Digital photography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
LED 620 nm group (G-LED 620)
The LED device in the red light spectrum, with a wavelength of 620 nm, will be applied over the full extent of the wound.
干预措施: Light emitting diodes (LED) (Device)
LED 940 nm group (G-LED 940)
The LED device in the infrared light spectrum, with a wavelength of 940 nm, will be applied over the full extent of the wound.
干预措施: Light emitting diodes (LED) (Device)
Fixed diphasic current group (G-DF)
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.
干预措施: Fixed diphasic current (Device)
Control group (G-C)
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.
结局指标
主要结局
Rate of ulcer healing - Digital photography
时间窗: Twelve weeks
Percentage (%)
次要结局
- Von frey digital analgesiometer(Twelve weeks)
- Infrared Plethysmography(Twelve weeks)
- Bioimpedance(Twelve weeks)
- Digital Durometer(Twelve weeks)
- Infrared thermography(Twelve weeks)
- Numerical pain scale(Twelve weeks)
研究者
Rinaldo Roberto de Jesus Guirro
Professor, PT, PhD
University of Sao Paulo
