OsteomyelitisNCT01137903
Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers
A study testing Conservative surgery, Ciprofloxacin and Amoxicillin-Potassium Clavulanate Combination in people with Osteomyelitis and Diabetic Foot, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis, Diabetic Foot, Diabetic Foot Ulcers
- What is being tested?
- Conservative surgery, Ciprofloxacin and Amoxicillin-Potassium Clavulanate Combination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
José Luis Lázaro Martínez
Madrid, Madrid, 28040
José Luis Lázaro Martínez, PhD, +34913942203, diabetes@enf.ucm.es
Esther Alicia García Morales, PhD
About this study
Official title: 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 .
- Conditions
- Osteomyelitis, Diabetic Foot, Diabetic Foot Ulcers
- Being tested
- Conservative surgery, Ciprofloxacin, Amoxicillin-Potassium Clavulanate Combination, Sulfamethoxazole trimethoprim
- Keywords
- Diabetic foot, Osteomyelitis, Diabetic foot ulcers, Foot infections
- Medical subject headings
- Osteomyelitis, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative surgeryProcedure or surgery
Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy
CiprofloxacinDrug
500 mg/ 12 hours during 90 days
Amoxicillin-Potassium Clavulanate CombinationDrug
875/125 mg/12 hours during 90 days
Sulfamethoxazole trimethoprimDrug
Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing medical treatment | Other | Antibiotic treatment within 90 days with:
Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole. Receives: Drug: Ciprofloxacin; Drug: Amoxicillin-Potassium Clavulanate Combination; Drug: Sulfamethoxazole trimethoprim |
| Patients undergoing surgical treatment | Other | Conservative surgical Minor amputation 7 days antibiotic after surgical Receives: Procedure: Conservative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healing patients
Number of diabetic foot ulcers healing in both arms.
Measured: 12 weeks
Secondary outcomes (4)
Reulceration
Analysis of re-ulceration events in both arms after healing in a 1 year follow-up
Measured: 1 year after healing
Healing time
Healing time in both arms
Measured: 12 weeks
Complications
Percentage of complications in both arms
Measured: 12 weeks
Quality of life
Quality of life related to health in both arms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Investigators
- José Luis Lázaro Martínez, PhD, Principal investigator, Universidad Complutense de MadridFrancisco Javier Aragón Sánchez, MD, PhD, Study chair, Hospital La Paloma Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137903
- Sponsor's protocol ID
- OM-2010
- Status last verified
- May 2010
- First submitted
- 4 Jun 2010
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lazaro-Martinez JL, Aragon-Sanchez J, Garcia-Morales E. Antibiotics versus conservative surgery for treating diabetic foot osteomyelitis: a randomized comparative trial. Diabetes Care. 2014;37(3):789-95. doi: 10.2337/dc13-1526. Epub 2013 Oct 15.
PubMed 24130347
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01137903
- Acronym / sponsor ID
- OM-2010
- Conditions
- Osteomyelitis, Diabetic Foot, Diabetic Foot Ulcers
- Keywords
- Diabetic foot, Osteomyelitis, Diabetic foot ulcers, Foot infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing medical treatment | Other | Drug: Ciprofloxacin, Drug: Amoxicillin-Potassium Clavulanate Combination, Drug: Sulfamethoxazole trimethoprimAntibiotic treatment within 90 days with: Ciprofloxacin Amoxicillin /Clavulanic acid. Trimethoprim /Sulfamethoxazole. |
| Patients undergoing surgical treatment | Other | Procedure: Conservative surgeryConservative surgical Minor amputation 7 days antibiotic after surgical |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative surgeryOsteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy | Procedure or surgery | Patients undergoing surgical treatment |
| Ciprofloxacin500 mg/ 12 hours during 90 days | Drug | Patients undergoing medical treatment |
| Amoxicillin-Potassium Clavulanate Combination875/125 mg/12 hours during 90 days | Drug | Patients undergoing medical treatment |
| Sulfamethoxazole trimethoprimTrimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas. | Drug | Patients undergoing medical treatment |
Primary outcome
Number of healing patients
Time frame: 12 weeks
Number of diabetic foot ulcers healing in both arms.
4 secondary outcomes
Reulceration
Time frame: 1 year after healing
Healing time
Time frame: 12 weeks
Complications
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
- Derived from this study: PubMed 24130347Lazaro-Martinez JL, Aragon-Sanchez J, Garcia-Morales E. Antibiotics versus conservative surgery for treating diabetic foot osteomyelitis: a randomized comparative trial. Diabetes Care. 2014;37(3):789-95. doi: 10.2337/dc13-1526. Epub 2013 Oct 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Luis Lázaro Martínez, PhD principal investigator
Universidad Complutense de Madrid
Francisco Javier Aragón Sánchez, MD, PhD study chair
Hospital La Paloma Las Palmas de Gran Canaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative surgery, Ciprofloxacin and Amoxicillin-Potassium Clavulanate Combination in people with Osteomyelitis and Diabetic Foot, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Luis Lázaro Martínez, PhD (+34913942203, diabetes@enf.ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of healing patients (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01137903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2010.