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Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137903
Recruitment Status : Unknown
Verified May 2010 by Universidad Complutense de Madrid.
Recruitment status was:  Recruiting
First Posted : June 7, 2010
Last Update Posted : June 7, 2010
Information provided by:
Universidad Complutense de Madrid

Brief 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 .

Condition or disease Intervention/treatment Phase
Osteomyelitis Diabetic Foot Diabetic Foot Ulcers Procedure: Conservative surgery Drug: Ciprofloxacin Drug: Amoxicillin-Potassium Clavulanate Combination Drug: Sulfamethoxazole trimethoprim Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers
Study Start Date : April 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Patients undergoing medical treatment

Antibiotic treatment within 90 days with:

Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole.

Drug: Ciprofloxacin
500 mg/ 12 hours during 90 days

Drug: Amoxicillin-Potassium Clavulanate Combination
875/125 mg/12 hours during 90 days

Drug: Sulfamethoxazole trimethoprim
Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.

Patients undergoing surgical treatment
Conservative surgical Minor amputation 7 days antibiotic after surgical
Procedure: Conservative surgery
Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy

Primary Outcome Measures :
  1. Number of healing patients [ Time Frame: 12 weeks ]
    Number of diabetic foot ulcers healing in both arms.

Secondary Outcome Measures :
  1. Reulceration [ Time Frame: 1 year after healing ]
    Analysis of re-ulceration events in both arms after healing in a 1 year follow-up

  2. Healing time [ Time Frame: 12 weeks ]
    Healing time in both arms

  3. Complications [ Time Frame: 12 weeks ]
    Percentage of complications in both arms

  4. Quality of life [ Time Frame: 12 weeks ]
    Quality of life related to health in both arms

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01137903

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Contact: José Luis Lázaro Martínez, PhD +34913942203

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José Luis Lázaro Martínez Recruiting
Madrid, Spain, 28040
Contact: José Luis Lázaro Martínez, PhD    +34913942203   
Sub-Investigator: Esther Alicia García Morales, PhD         
Sub-Investigator: Silvia Allas Aguado, DP         
Sub-Investigator: Máximo Antonio González Jurado, RN, DP, PhD         
Sub-Investigator: Gabriel Rivera San Martín, DP         
Sub-Investigator: María del Carmen García Carrión, MD, PhD         
Sub-Investigator: Juan Vicente Beneit Montesinos, MD,PhD         
Principal Investigator: José Luis Lázaro Martínez, PhD         
Principal Investigator: Franciso Javier Aragón Sánchez, MD, PhD         
Sub-Investigator: Almudena Cecilia Matilla, DP         
Sub-Investigator: Yolanda García Álvarez, RN, DP         
Sponsors and Collaborators
Universidad Complutense de Madrid
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Principal Investigator: José Luis Lázaro Martínez, PhD Universidad Complutense de Madrid
Study Chair: Francisco Javier Aragón Sánchez, MD, PhD Hospital La Paloma Las Palmas de Gran Canaria
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: José Luis Lázaro Martínez/Professor, Universidad Complutense de Madrid Identifier: NCT01137903    
Other Study ID Numbers: OM-2010
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: May 2010
Keywords provided by Universidad Complutense de Madrid:
Diabetic foot
Diabetic foot ulcers
Foot infections
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Clavulanic Acid
Clavulanic Acids
Trimethoprim, Sulfamethoxazole Drug Combination
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents