drugset / Trial / NCT01137903

Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

NCT01137903 ↗

Unknown 88 enrolled Universidad Complutense de Madrid
RandomizedCrossoverOpen-labelTreatment

Summary

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 .

Timeline

Start
2010-04
Primary completion
2011-04
Completion
2011-11

Outcome

Missed primary endpoint

paper Eighteen patients (75%) achieved primary healing in the AG, and 19 (86.3%) in the SG (P = 0.33). PMID 24130347 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 875 mg —
Subject Ciprofloxacin Small molecule 500 mg —
Subject Clavulanate Unknown 125 mg —
Subject Sulfamethoxazole Small molecule 800 mg —
Subject Trimethoprim Small molecule 160 mg —