Status:
UNKNOWN
Analysis of the Effects of LED Phototherapy and Electrical Stimulation in the Healing of Diabetic Ulcers
Lead Sponsor:
University of Sao Paulo
Conditions:
Ulcer
Diabetes Mellitus
Eligibility:
All Genders
30-65 years
Phase:
NA
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 vasc...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03250533
Start Date
September 1 2017
End Date
June 30 2021
Last Update
August 21 2017
Active Locations (1)
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1
University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900