Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Universidad Complutense de Madrid.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Universidad Complutense de Madrid

ClinicalTrials.gov Identifier:

NCT01137903

First received: June 4, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Purpose

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
Osteomyelitis 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 Endpoint Classification: Efficacy Study 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:

MedlinePlus related topics: Antibiotics Diabetic Foot Foot Health Potassium

Drug Information available for: Potassium bicarbonate Sulfamethoxazole Trimethoprim Potassium chloride Amoxicillin Amoxicillin sodium Trimethoprim hydrochloride Clavulanate potassium Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Universidad Complutense de Madrid:

Primary Outcome Measures:

Number of healing patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Number of diabetic foot ulcers healing in both arms.

Secondary Outcome Measures:

Reulceration [ Time Frame: 1 year after healing ] [ Designated as safety issue: No ]
Analysis of re-ulceration events in both arms after healing in a 1 year follow-up
Healing time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Healing time in both arms
Complications [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage of complications in both arms
Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137903

Contacts

Contact: José Luis Lázaro Martínez, PhD	+34913942203	diabetes@enf.ucm.es
Contact: José Luis Lázaro Martínez, Phd	+34913942203	diabetes@enf.ucm.es

Locations

Spain
José Luis Lázaro Martínez	Recruiting
Madrid, Spain, 28040
Contact: José Luis Lázaro Martínez, PhD +34913942203 diabetes@enf.ucm.es
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

Investigators

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

No publications provided

Responsible Party:	José Luis Lázaro Martínez/Professor, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:	NCT01137903 History of Changes
Other Study ID Numbers:	OM-2010
Study First Received:	June 4, 2010
Last Updated:	June 4, 2010
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad Complutense de Madrid:

Diabetic foot
Osteomyelitis
Diabetic foot ulcers
Foot infections

Additional relevant MeSH terms:

Diabetic Foot
Osteomyelitis
Ulcer
Foot Ulcer
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases

Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Ciprofloxacin
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 18, 2013

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