Efficacy of Surgical Treatment of Osteomyelitis in Diabet... | NCT01137903 | Trialant
NCT01137903
Sponsor
Universidad Complutense de Madrid
Status
Unknown status
Last Update Posted
Jun 7, 2010Estimated
Enrollment
88Estimated
Phase
Not Applicable
Conditions
Osteomyelitis
Diabetic Foot
Diabetic Foot Ulcers
Interventions
Conservative surgery
Ciprofloxacin
Amoxicillin-Potassium Clavulanate Combination
Sulfamethoxazole trimethoprim
Countries
Spain
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01137903
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
OM-2010
Secondary IDs
Not provided
Brief Title
Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Official Title
Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Acronym
Not provided
Organization
Universidad Complutense de MadridOTHER
Status Module
Record Verification Date
May 2010
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2010
Primary Completion Date
Apr 2011Estimated
Completion Date
Nov 2011Estimated
First Submitted Date
Jun 4, 2010
First Submission Date that Met QC Criteria
Jun 4, 2010
First Posted Date
Jun 7, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 4, 2010
Last Update Posted Date
Jun 7, 2010Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Universidad Complutense de MadridOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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 .
Conservative surgical Minor amputation 7 days antibiotic after surgical
Procedure: Conservative surgery
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Conservative surgery
Procedure
Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy
Patients undergoing surgical treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of healing patients
Number of diabetic foot ulcers healing in both arms.
12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Reulceration
Analysis of re-ulceration events in both arms after healing in a 1 year follow-up
1 year after healing
Healing time
Healing time in both arms
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients with Diabetes Mellitus Type 1 or 2.
Patients with diabetic foot ulcers.
Patients with clinical suspects of osteomyelitis.
Patients with positive probe to bone test.
Patients with signs of osteolysis in the bone located adjacent to the ulcer in X-Ray
Patients with transcutaneous oxygen oxygenation above 30 mmHg.
Acceptance to participate in the study through prior informed consent.
Exclusion Criteria:
Patients with osteomyelitis associated with necrotizing soft tissue infections.
Presence of necrotic tissue in the wound bed, edges or margins of the lesion.
HbAc1 > 10.
Presence of systemic toxicity such as fever, tachycardia, confusion, disorientation, vomiting or other signs usually related to systemic infection.
Patients with bone exposure through the ulcer.
Patients with absent pulses, ankle/brachial index (ABI) <0.8 and TcPO2 <30 mmHg.
Pregnancy.
Allergies to antibiotics.
Any degree of renal impairment that contraindicated the administration of antibiotics proposed.
Hepatic insufficiency.
Mental Illnesses that prevent the understanding by the patient's proposed treatment, or for any other reason associated with your mental health, to recommend their inclusion.
Lazaro-Martinez JL, Aragon-Sanchez J, Garcia-Morales E. Antibiotics versus conservative surgery for treating diabetic foot osteomyelitis: a randomized comparative trial. Diabetes Care. 2014;37(3):789-95. doi: 10.2337/dc13-1526. Epub 2013 Oct 15.