Osteomyelitis of Lower ExtremitiesNCT07251374
Osteomyelitis Multi-center Prospective Cohort Study
An observational study of Osteomyelitis of Lower Extremities, run by Southwest Hospital, China at 1 site in China.
Trial summary
To establish a prospective, multicenter, real-world cohort of patients with osteomyelitis, by systematically collecting and analyzing detailed treatment and follow-up data, in order to provide clinical evidence for the standardization of its treatment Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteomyelitis of Lower Extremities
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 30 Sep 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of real-world patients with osteomyelitis from multiple centers. Based on the treatment received, participants will be retrospectively assigned to either a conservative therapy cohort or a surgical therapy cohort for analysis.
Who may be able to join
- Signed informed consent provided.
- Diagnosis of osteomyelitis confirmed by the site per guidelines (including definitive/suggestive criteria).
Who cannot join
- Patients who, in the opinion of the investigator, are unable to comply with the entire study procedure (including postoperative management and regular follow-up) due to psychiatric, cognitive, or behavioral disorders, or other objective reasons.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital Affiliated to Army Medical University
Chongqing, Chongqing Municipality
Dong Sun, MD, +86 151 2326 1488, sumersun07@126.com
Jing Fu, +86 186 2300 0909, 297114777@qq.com
About this study
Official title: Construction of a Multicenter Disease-Specific Database and Prospective Cohort for Osteomyelitis
To establish a prospective, multicenter, real-world cohort of patients with osteomyelitis, by systematically collecting and analyzing detailed treatment and follow-up data, in order to provide clinical evidence for the standardization of its treatment
Read the detailed description
Study Design： This is a prospective, multi-center, real-world clinical study. Subjects will be assigned to different treatment regimens based on their diagnosis and differential diagnosis.
Conservatively Treated Cohort: Patients with bone infection who do not meet the criteria for surgical intervention will receive conservative therapy, which includes intravenous (IV) and oral antibiotics.
Surgically Treated Cohort: Patients meeting the surgical indications will undergo a staged surgical protocol. The first stage involves debridement and implantation of antibiotic-impregnated bone cement. The need for auxiliary internal or external fixation will be determined based on the patient's condition. The second stage, performed 8 weeks after the first, focuses on repairing the bone defect.
All treatments will be conducted in accordance with current clinical practice guidelines. This study is purely observational; it will only monitor and collect data on changes in relevant parameters during the treatment process without interfering with any other clinical decisions.
Data Collection：
The following information will be recorded and collected:
- Unique subject identifier and basic demographic information.
- Baseline status and information prior to treatment.
- Key information related to the surgery.
- Post-operative follow-up information, including:
（1）Pain score (Visual Analog Scale, VAS) （2)Quality of life (Short Form-36, SF-36) (3)Self-Rating Anxiety Scale (SAS) score (4)Limb function score (Disabilities of the Arm, Shoulder and Hand / Lower Extremity Functional Scale, DASH/LEFS) (5)Range of motion of adjacent joints (6)Occurrence of complications.
Complications include:
- Surgical incision complications (e.g., dehiscence, skin necrosis).
- Pin tract infection.
- Fixation failure or breakage.
- Reduced joint range of motion.
- Other discomforts deemed by the investigator to be related to the surgery.
Cohort Stratification:
To comprehensively describe the clinical characteristics and outcomes of bone infection, the study data will be stratified into cohorts based on the real-world treatment received by the patients. Patients will be categorized into cohorts according to the actual treatment modality they received, with each treatment type constituting a separate cohort. All cohort classifications will be performed after data collection is complete, based on predefined criteria, and will not involve proactive intervention by the investigators.
- Conditions
- Osteomyelitis of Lower Extremities
- Keywords
- Osteomyelitis, Multi-center, Prospective, Disease-Specific Database
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgically Treated Cohort | All treatments will be conducted in accordance with existing clinical practice guidelines. This study is purely observational; it will only monitor and collect data on changes in relevant parameters during the subjects' treatment process without interfering with any other clinical decisions. Enrolled subjects will be assigned to different treatment regimens based on their diagnosis and differential diagnosis. Patients with bone infection who do meet the criteria for surgical intervention will receive conservative therapy. | |
| Conservatively Treated Cohort | All treatments will follow current standards of care. This is an observational study that collects data on treatment outcomes without intervening in clinical management. Patients who meeting the surgical indications will undergo surgical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection control rate at week 8 after treat
Patients will return for a follow-up visit at 8 weeks post-treatment. The assessment will include evaluation of the incision condition, documentation of afebrile status, and repeat laboratory tests including CBC (WBC count), ESR, and CRP
Measured: 8 weeks after operation
Secondary outcomes (5)
Disability of Arm Shoulder and Hand Scale（DASH）
This outcome measure is applicable only to patients presenting with upper extremity symptoms or dysfunction.Patients will be guided by study staff to complete the questionnaire based on their actual condition.
Disability of Arm Shoulder and Hand Scale（DASH）：
- Scoring: The total score ranges from 0 to 100.
- Interpretation: A score of 0 indicates no disability (normal upper extremity function), while a score of 100 indicates severe disability (extremely limited upper extremity function).
Measured: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
The 36-Item Short Form Health Survey
Patients will be guided by study staff to complete the questionnaire based on their actual condition.
- Scoring: The total score ranges from 0 to 900.
- Interpretation:The 36-Item Short Form Health Survey（SF-36）assesses health status across nine dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), Mental Health (MH), and Health Transition (HT). For all scales, higher scores indicate a better health status for the respondent.
Measured: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Self-Rating Anxiety Scale (SAS)
Patients will be guided by study staff to complete the questionnaire based on their actual condition.
- Scoring: The total score ranges from 0 to 80.The standard cutoff for anxiety is a score of 50.
- Interpretation:Mild anxiety: 50-59；Moderate anxiety: 60-69；Severe anxiety: 70 and above.
Measured: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Pain score (assessed by Visual Analogue Scale)
Patients will be guided by study staff to complete the questionnaire based on their actual condition.
- Scoring: The total score ranges from 0 to 10.
- Interpretation: A score of 0 indicates "No Pain"；A score of 10 indicates "The Worst Possible Pain" (or "Severe/Excruciating Pain").
Measured: Pre-treatment;At 2 weeks post-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Lower Extremity Functional Scale
This outcome measure is applicable only to patients presenting with lower extremity symptoms or dysfunction. Patients will be guided by study staff to complete the questionnaire based on their actual condition.
Lower Extremity Functional Scale（LEFS）：
- Scoring: The total score ranges from 0 to 80.
- Interpretation: A higher score indicates a higher level of lower extremity function. Conversely, a lower score indicates greater functional limitation.
Measured: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start10 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteomyelitis of Lower ExtremitiesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Sun, Southwest Hospital, China
- Investigators
- Dong Sun, MD, Principal investigator, The First Hospital Affiliated of Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251374
- Sponsor's protocol ID
- (A)KY2025236
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Multicenter Disease-Specific Database and Prospective Cohort for Osteomyelitis
- ClinicalTrials.gov ID
- NCT07251374
- Acronym / sponsor ID
- (A)KY2025236
- Conditions
- Osteomyelitis of Lower Extremities
- Keywords
- Osteomyelitis, Multi-center, Prospective, Disease-Specific Database
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 26 Nov 2025 (actual)
- 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.
To establish a prospective, multicenter, real-world cohort of patients with osteomyelitis, by systematically collecting and analyzing detailed treatment and follow-up data, in order to provide clinical evidence for the standardization of its treatment
Detailed description
Study Design： This is a prospective, multi-center, real-world clinical study. Subjects will be assigned to different treatment regimens based on their diagnosis and differential diagnosis.
Conservatively Treated Cohort: Patients with bone infection who do not meet the criteria for surgical intervention will receive conservative therapy, which includes intravenous (IV) and oral antibiotics.
Surgically Treated Cohort: Patients meeting the surgical indications will undergo a staged surgical protocol. The first stage involves debridement and implantation of antibiotic-impregnated bone cement. The need for auxiliary internal or external fixation will be determined based on the patient's condition. The second stage, performed 8 weeks after the first, focuses on repairing the bone defect.
All treatments will be conducted in accordance with current clinical practice guidelines. This study is purely observational; it will only monitor and collect data on changes in relevant parameters during the treatment process without interfering with any other clinical decisions.
Data Collection：
The following information will be recorded and collected:
- Unique subject identifier and basic demographic information.
- Baseline status and information prior to treatment.
- Key information related to the surgery.
- Post-operative follow-up information, including:
（1）Pain score (Visual Analog Scale, VAS) （2)Quality of life (Short Form-36, SF-36) (3)Self-Rating Anxiety Scale (SAS) score (4)Limb function score (Disabilities of the Arm, Shoulder and Hand / Lower Extremity Functional Scale, DASH/LEFS) (5)Range of motion of adjacent joints (6)Occurrence of complications.
Complications include:
- Surgical incision complications (e.g., dehiscence, skin necrosis).
- Pin tract infection.
- Fixation failure or breakage.
- Reduced joint range of motion.
- Other discomforts deemed by the investigator to be related to the surgery.
Cohort Stratification:
To comprehensively describe the clinical characteristics and outcomes of bone infection, the study data will be stratified into cohorts based on the real-world treatment received by the patients. Patients will be categorized into cohorts according to the actual treatment modality they received, with each treatment type constituting a separate cohort. All cohort classifications will be performed after data collection is complete, based on predefined criteria, and will not involve proactive intervention by the investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgically Treated Cohort | – | –All treatments will be conducted in accordance with existing clinical practice guidelines. This study is purely observational; it will only monitor and collect data on changes in relevant parameters during the subjects' treatment process without interfering with any other clinical decisions. Enrolled subjects will be assigned to different treatment regimens based on their diagnosis and differential diagnosis. Patients with bone infection who do meet the criteria for surgical intervention will receive conservative therapy. |
| Conservatively Treated Cohort | – | –All treatments will follow current standards of care. This is an observational study that collects data on treatment outcomes without intervening in clinical management. Patients who meeting the surgical indications will undergo surgical treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of real-world patients with osteomyelitis from multiple centers. Based on the treatment received, participants will be retrospectively assigned to either a conservative therapy cohort or a surgical therapy cohort for analysis.
Key inclusion criteria (2 listed)
- Signed informed consent provided.
- Diagnosis of osteomyelitis confirmed by the site per guidelines (including definitive/suggestive criteria).
Key exclusion criteria (2 listed)
- Patients who, in the opinion of the investigator, are unable to comply with the entire study procedure (including postoperative management and regular follow-up) due to psychiatric, cognitive, or behavioral disorders, or other objective reasons.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infection control rate at week 8 after treat
Time frame: 8 weeks after operation
Patients will return for a follow-up visit at 8 weeks post-treatment. The assessment will include evaluation of the incision condition, documentation of afebrile status, and repeat laboratory tests including CBC (WBC count), ESR, and CRP
5 secondary outcomes
Disability of Arm Shoulder and Hand Scale（DASH）
Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
The 36-Item Short Form Health Survey
Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Self-Rating Anxiety Scale (SAS)
Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Pain score (assessed by Visual Analogue Scale)
Time frame: Pre-treatment;At 2 weeks post-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Lower Extremity Functional Scale
Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Dong Sun, MD principal investigator
The First Hospital Affiliated of Army Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis of Lower Extremities, run by Southwest Hospital, China at 1 site in China.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Nov 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Sun, MD (+86 151 2326 1488, sumersun07@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection control rate at week 8 after treat (time frame: 8 weeks after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.