Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers (NCT01137903) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Spain88 participantsStarted 2010-04
Plain-language 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 .
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.