NCT01137903

Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Osteomyelitis
• Diabetic Foot
• Diabetic Foot Ulcers

Interventions

Type	Name	Description
PROCEDURE	Conservative surgery	Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy
DRUG	Ciprofloxacin	500 mg/ 12 hours during 90 days
DRUG	Amoxicillin-Potassium Clavulanate Combination	875/125 mg/12 hours during 90 days
DRUG	Sulfamethoxazole trimethoprim	Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-04-01
• Completion: 2011-11-01
• First posted: 2010-06-07
• Last updated: 2010-06-07

Locations

1 site across 1 country: Spain