Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-11-30

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 .

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Detailed Description

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Conditions

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Osteomyelitis Diabetic Foot Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients undergoing medical treatment

Antibiotic treatment within 90 days with:

Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.

Group Type OTHER

Ciprofloxacin

Intervention Type DRUG

500 mg/ 12 hours during 90 days

Amoxicillin-Potassium Clavulanate Combination

Intervention Type DRUG

875/125 mg/12 hours during 90 days

Sulfamethoxazole trimethoprim

Intervention Type DRUG

Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.

Patients undergoing surgical treatment

Conservative surgical Minor amputation 7 days antibiotic after surgical

Group Type OTHER

Conservative surgery

Intervention Type PROCEDURE

Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy

Interventions

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Conservative surgery

Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy

Intervention Type PROCEDURE

Ciprofloxacin

500 mg/ 12 hours during 90 days

Intervention Type DRUG

Amoxicillin-Potassium Clavulanate Combination

875/125 mg/12 hours during 90 days

Intervention Type DRUG

Sulfamethoxazole trimethoprim

Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No