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Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Universidad Complutense de Madrid.
Recruitment status was:  Recruiting
Information provided by:
Universidad Complutense de Madrid Identifier:
First received: June 4, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
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 Intervention
Diabetic Foot
Diabetic Foot Ulcers
Procedure: Conservative surgery
Drug: Ciprofloxacin
Drug: Amoxicillin-Potassium Clavulanate Combination
Drug: Sulfamethoxazole trimethoprim

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Resource links provided by NLM:

Further study details as provided by Universidad Complutense de Madrid:

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

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

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

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

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

Estimated Enrollment: 88
Study Start Date: April 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT01137903

Contact: José Luis Lázaro Martínez, PhD +34913942203

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
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: José Luis Lázaro Martínez/Professor, Universidad Complutense de Madrid Identifier: NCT01137903     History of Changes
Other Study ID Numbers: OM-2010
Study First Received: June 4, 2010
Last Updated: June 4, 2010

Keywords provided by Universidad Complutense de Madrid:
Diabetic foot
Diabetic foot ulcers
Foot infections

Additional relevant MeSH terms:
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
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 21, 2017