Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Not Applicable

• Conditions: Osteomyelitis; Diabetic Foot; Diabetic Foot Ulcers
• Interventions: Drug: Ciprofloxacin; Procedure: Conservative surgery; Drug: Amoxicillin-Potassium Clavulanate Combination; Drug: Sulfamethoxazole trimethoprim

• Registration Number: NCT01137903
• Lead Sponsor: Universidad Complutense de Madrid

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2010-05
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Last Update Submitted: 2010-06-04
• Study First Posted: 2010-06-07
• Last Update Posted: 2010-06-07
• Primary Completion: 2011-04
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patients undergoing medical treatment	Ciprofloxacin	Antibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.
Patients undergoing medical treatment	Amoxicillin-Potassium Clavulanate Combination	Antibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.
Patients undergoing medical treatment	Sulfamethoxazole trimethoprim	Antibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.
Patients undergoing surgical treatment	Conservative surgery	Conservative surgical Minor amputation 7 days antibiotic after surgical

Primary Outcome Measures

Name	Time	Method
Number of healing patients	12 weeks	Number of diabetic foot ulcers healing in both arms.

Secondary Outcome Measures

Name	Time	Method
Reulceration	1 year after healing	Analysis of re-ulceration events in both arms after healing in a 1 year follow-up
Healing time	12 weeks	Healing time in both arms
Complications	12 weeks	Percentage of complications in both arms
Quality of life	12 weeks	Quality of life related to health in both arms

Trial Locations

Locations (1)

José Luis Lázaro Martínez; 🇪🇸 Madrid, Spain