- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01137903
Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers
June 4, 2010 updated by: Universidad Complutense de Madrid
Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers
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 .
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: José Luis Lázaro Martínez, PhD
- Phone Number: +34913942203
- Email: diabetes@enf.ucm.es
Study Locations
-
-
-
Madrid, Spain, 28040
- Recruiting
- José Luis Lázaro Martínez
-
Contact:
- José Luis Lázaro Martínez, PhD
- Phone Number: +34913942203
- Email: 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:
- Franciso Javier Aragón Sánchez, MD, PhD
-
Sub-Investigator:
- Almudena Cecilia Matilla, DP
-
Sub-Investigator:
- Yolanda García Álvarez, RN, DP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients undergoing medical treatment
Antibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole. |
500 mg/ 12 hours during 90 days
875/125 mg/12 hours during 90 days
Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.
|
Other: Patients undergoing surgical treatment
Conservative surgical Minor amputation 7 days antibiotic after surgical
|
Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of healing patients
Time Frame: 12 weeks
|
Number of diabetic foot ulcers healing in both arms.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reulceration
Time Frame: 1 year after healing
|
Analysis of re-ulceration events in both arms after healing in a 1 year follow-up
|
1 year after healing
|
Healing time
Time Frame: 12 weeks
|
Healing time in both arms
|
12 weeks
|
Complications
Time Frame: 12 weeks
|
Percentage of complications in both arms
|
12 weeks
|
Quality of life
Time Frame: 12 weeks
|
Quality of life related to health in both arms
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Anticipated)
April 1, 2011
Study Completion (Anticipated)
November 1, 2011
Study Registration Dates
First Submitted
June 4, 2010
First Submitted That Met QC Criteria
June 4, 2010
First Posted (Estimate)
June 7, 2010
Study Record Updates
Last Update Posted (Estimate)
June 7, 2010
Last Update Submitted That Met QC Criteria
June 4, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Infections
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Infectious
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Osteomyelitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Cytochrome P-450 CYP1A2 Inhibitors
- beta-Lactamase Inhibitors
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Ciprofloxacin
- Amoxicillin
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
- Clavulanic Acid
- Clavulanic Acids
- Amoxicillin-Potassium Clavulanate Combination
Other Study ID Numbers
- OM-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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