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Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

NCT01137903 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2010-06-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • José Luis Lázaro Martínez, PhD · Universidad Complutense de Madrid

  • Francisco Javier Aragón Sánchez, MD, PhD · Hospital La Paloma Las Palmas de Gran Canaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-04-30
Completion
2011-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137903 on ClinicalTrials.gov