Hypothesis:Surgical treatment of osteomyelitis in diabetic foot is more effective that medical treatment through antibiotherapy and leads wound healing in ulcers complicated with bone infection.Material and Methods: Randomized clinical trials which include two groups of patients (n=88), one receives medical treatment through antibiotherapy during 90 days and the other group receive conservative surgical treatment and antibiotics during 7 days after surgery. It will be studied differences between both groups in healing time, recidives, present and relationship of adverse events and outflow of quality of life related health .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy
500 mg/ 12 hours during 90 days
875/125 mg/12 hours during 90 days
Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.
José Luis Lázaro Martínez
Madrid, Madrid, Spain
RECRUITINGNumber of healing patients
Number of diabetic foot ulcers healing in both arms.
Time frame: 12 weeks
Reulceration
Analysis of re-ulceration events in both arms after healing in a 1 year follow-up
Time frame: 1 year after healing
Healing time
Healing time in both arms
Time frame: 12 weeks
Complications
Percentage of complications in both arms
Time frame: 12 weeks
Quality of life
Quality of life related to health in both arms
Time frame: 12 weeks
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