Overview

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.