Diabetic Foot Ulcer
Conditions
Interventions
This study consists of a randomized controlled, multicenter, double-blind, prospective phase II clinical trial of three arms of treatments for patients with diabetic ulcers, obtaining a binary primary
Sponsors
Universidade Federal do Ceará
Universidade Federal do Ceará
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Diabetic patients; of both genders; outpatient clinics with neuropathic diabetic ulcers; aged between 18 and 80 years; with a maximum of 4 weeks of lesion development
Exclusion criteria
Exclusion criteria: Those with a known allergy to any of the components of the dressings; to possess ulceration with exposed tendon, periosteum or bone, bone infection (osteomyelitis acute) and soft tissue infection requiring treatment with systemic antibiotics; ulcer on a limb being considered for revascularization or debridement surgical; patients receiving medications (such as corticosteroids, immunosuppressants or chemotherapy) in the last six months before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find complete re-epithelialization of the wound within 24 consecutive weeks of care, verified using the DUFAS-Br instrument, with a reduction in the scale score pre and post intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| t is expected to find absence or reduction in the growth of microorganisms, verified through wound secretion culture, based on the finding of a reduction in the Colony Forming Units (CFU) count rate. | — |
Countries
Brazil
Contacts
Public ContactRodrigo Vieira
Universidade Federal do Ceará
Outcome results
None listed