Status:
UNKNOWN
Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Lead Sponsor:
Universidad Complutense de Madrid
Conditions:
Osteomyelitis
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
NA
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.Materi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01137903
Start Date
April 1 2010
End Date
November 1 2011
Last Update
June 7 2010
Active Locations (1)
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1
José Luis Lázaro Martínez
Madrid, Madrid, Spain, 28040