Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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 .

Official Title
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Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Conditions
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Osteomyelitis, Diabetic Foot, Diabetic Foot Ulcers

Intervention / Treatment
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* Procedure: Conservative surgery
* Drug: Ciprofloxacin
* Drug: Amoxicillin-Potassium Clavulanate Combination
* Drug: Sulfamethoxazole trimethoprim


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients undergoing medical treatment<br>Antibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole. | Drug: Ciprofloxacin<br>* 500 mg/ 12 hours during 90 days<br>Drug: Amoxicillin-Potassium Clavulanate Combination<br>* 875/125 mg/12 hours during 90 days<br>Drug: Sulfamethoxazole trimethoprim<br>* Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.<br>|
| Other: Patients undergoing surgical treatment<br>Conservative surgical Minor amputation 7 days antibiotic after surgical | Procedure: Conservative surgery<br>* Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of healing patients | Number of diabetic foot ulcers healing in both arms. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reulceration | Analysis of re-ulceration events in both arms after healing in a 1 year follow-up | 1 year after healing | 
| Healing time | Healing time in both arms | 12 weeks | 
| Complications | Percentage of complications in both arms | 12 weeks | 
| Quality of life | Quality of life related to health in both arms | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot, Osteomyelitis, Diabetic foot ulcers, Foot infections