Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Universidad Complutense de Madrid

Status: Unknown

Conditions: Diabetic Foot; Diabetic Foot Ulcers; Osteomyelitis

Treatments: Drug: Ciprofloxacin; Drug: Sulfamethoxazole trimethoprim; Procedure: Conservative surgery; Drug: Amoxicillin-Potassium Clavulanate Combination

Study type: Interventional

Funder types: Other

Identifiers

NCT01137903

OM-2010

Details and patient eligibility

About

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 .

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Patients undergoing medical treatment

Other group

Description:

Antibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.

Treatment:

Drug: Amoxicillin-Potassium Clavulanate Combination

Drug: Ciprofloxacin

Drug: Sulfamethoxazole trimethoprim

Patients undergoing surgical treatment

Other group

Description:

Conservative surgical Minor amputation 7 days antibiotic after surgical

Treatment:

Procedure: Conservative surgery