Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT01137903
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01137903
Study Brief:
Protocol Section:
NCT01137903