Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

• Status: Unknown status
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Complutense de Madrid
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ciprofloxacin; Clavulanic Acid; Clavulanic Acids; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

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.