Diabetic Foot InfectionsPhase 2NCT00685698
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
A Phase 2 study testing TG-873870 (Nemonoxacin) in people with Diabetic Foot Infections, run by TaiGen Biotechnology Co., Ltd. at 16 sites in 4 countries.
Trial summary
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infections
- What is being tested?
- TG-873870 (Nemonoxacin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Jun 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Body weight ≥ 40 kg
- Previously known or newly diagnosed diabetes mellitus, including type 1 and type 2 (per the American Diabetes Association guidelines), which is controlled by proper lifestyle (diet, exercise) or treatment with either oral medications or insulin
- Patients' HbA1c ≦ 12% at screening
- Clinically defined diabetic foot infection of mild or moderate severity (PEDIS grade 2-3) as based on the guideline of the Infectious Diseases Society of America. It includes any inframalleolar infection of the soft-tissue, such as paronychia, cellulitis, myositis, abscesses, and tendonitis
- Evidence of necrotic tissue, purulent collections or abscess that may require excision, incision or drainage (based on investigator's judgment, and a surgeon if needed)
- Must be able to provide suitable tissue specimens (preferably obtained by biopsy or tissue curettage, or purulent fluid aspiration, rather than by swabbing) from the infected wound (after appropriate cleansing and debridement) for Gram-staining and bacterial cultures (aerobes and anaerobes)
- A confirmed Gram-positive pathogen infection by Gram-stain. The criterion to determine patient's eligibility for study recruitment is a Gram-stained smear with at least 1 Gram-positive organism seen in at least two high power fields. A solely Gram-positive pathogen infection or a polymicrobial infection including Gram-positive and Gram-negative pathogens are acceptable within the framework of the study
Who cannot join
- A co-morbid disease condition that could compromise evaluation or participation in this study, such as severe hepatic disease (e.g., active hepatitis, decompensated liver cirrhosis), renal failure (estimated creatinine clearance [CrCl] <30 ml/minute or need for hemodialysis or peritoneal dialysis), or active systemic malignancy (advanced or metastatic), unless enrollment is deemed appropriate at the discretion of the Investigator with prior consultation with the study Medical Monitor
- History of prolonged QTc interval or a medical condition requiring the use of a concomitant medication that is associated with an increased QTc interval (e.g., class I or class III anti-arrhythmic agents)
- Contact dermatitis over the infected skin area, infected third-degree burn wounds, necrotizing fascitis, extensive gangrene, pyoderma gangrenosum, deep vein thrombosis, shock, or any medical disorder that could either interfere with the evaluation of treatment or the response of the patient to therapy
- Radiological evidence of bone or joints infection within 7 days prior to or at screening, i.e. potential osteomyelitis or septic arthritis
- Clinically defined uninfected or severe infection (PEDIS grade 1 or 4) as based on the Infectious Diseases Society of America classification system
- Any known severe immunosuppressive condition, such as an active hematological malignancy, HIV infection or active treatment with any immunosuppressive drug (including corticosteroids at a dose of >20 mg/day of prednisone, or its equivalent)
Show all 12Show fewer
- Has received or will be receiving chemotherapy or oncolytics within six months prior to entering or during the study
- History of current or active alcohol abuse (>3 drinks daily or binge drinking) or any illicit drug use
- Known or suspected critical ischemia of the affected limb (based on investigators' clinical judgments and vascular assessment)
- Wound that contains or is proximate to any prosthetic materials or devices that is/are not scheduled for removal
- Patient with a foot infection that, in the investigator's judgment, is severe enough to require hospitalization or intravenous antibiotic therapy
- Neutrophil count <1000 cells/mm3
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Taiwan7 sites
Chang Gung Memorial Hospital- Kaoshiung, Taiwan
Kaohsiung City
Cheng Ching Hospital, Taichung, Taiwan
Taichung
Chi-Mei Medical Center, Tainan, Taiwan
Tainan
Cardinal Tien Hospital (CTH), Taiwan
Taipei
Tri-Service General Hospital, Taipei, Taiwan
Taipei
Wan Fang Hospital
Taipei
Cheng-Gung Memorial Hospital - LinKou, Taiwan
Taoyuan
South Africa5 sites
Eastmed Academic Clinical Trial Center
East Lynne, Gauteng
Jubilee Clinical Trial Center
Hammanskraal, Gauteng
Mercantile Clinical Trial Center
Korsten, Port Elizabeth
Montana Hospital
Pretoria, Gauteng
Park Medical Center
Witbank, Gauteng
United States3 sites
The Amputation Prevention Center at Broadlawns Medical Center
Des Moines, Iowa, 50314
HealthCare Partners
Montebello, California, 90640
HealthCare Partners
Pasadena, California, 91105
About this study
Official title: An Open-Label, Single-Arm, Multi-Center Study of TG-873870 for Treating Patients With Diabetic Foot Infections of Mild to Moderate Severity Associated With Gram-Positive Pathogens
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
Read the detailed description
This study will assess the safety and efficacy of TG-873870 (Nemonoxacin) in patients with Diabetic Foot Infections. Pharmacokinetic (PK) and pharmacodynamic (PD) assessment will be conducted in a subgroup of eight consenting patients.
- Conditions
- Diabetic Foot Infections
- Being tested
- TG-873870 (Nemonoxacin)
- Keywords
- Diabetic Foot Infections, DFI, Nemonoxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-873870 (Nemonoxacin)Drug
Also called Taigexyn
750 mg
| Study group | Role | What they receive |
|---|---|---|
| Nemonoxacin | Other | Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. Receives: Drug: TG-873870 (Nemonoxacin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success (in ITT Population)
Clinical Success
- Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
- Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions.
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Secondary outcomes (18)
Microbiological Success Rate
Microbiological Success
- Eradicated, defined as absence of the original pathogen(s) from a repeat culture of the original infection site performed at the TOC visit.
- Presumed Eradicated, defined as meeting the definition for Clinical Success at the TOC visit, but tissue sample could be obtained for culture from the original infection site.
- TOC=Test of Cure
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Clinical Success (in PP Population)
Clinical Success
- Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
- Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions.
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Clinical Success (at End of Treatment/Early Termination)
Clinical Success
- Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.
- Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions.
Measured: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Per-Pathogen Clinical Responses (at Test of Cure)
Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Per-Pathogen Clinical Response (at End of Treatment/Early Termination)
Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at at End of Treatment/Early Termination within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.
Measured: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Per-Pathogen Microbiological Responses
Microbiological responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Microbiological Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Microbiological Success rates for Streptococcus pyogenes in the PP population.
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Total Wound Score (at Test of Cure in ITT Population)
The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.
Measured: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Total Wound Score (at Test of Cure in PP Population)
The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.
Measured: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Total Wound Score (at End of Treatment/ Early Termination in ITT Population)
The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and End of Treatment/ Early Termination visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.
Measured: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Total Wound Score (at End of Treatment/ Early Termination in PP Population)
The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.
Measured: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population
The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.
Measured: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population
The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population
The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.
Measured: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population
The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)
Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.
Measured: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)
Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)
Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.
Measured: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)
Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.
Measured: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot InfectionsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kuang-Chung Shih, M.D., Study chair, Tri-Service General Hospital, Taipei, TaiwanJawl-Shan Hwang, M.D., Principal investigator, Cheng-Gung Memorial Hospital - LinKou, TaiwanTe-Lin Hsia, M.D., Principal investigator, Cardinal Tien Hospital (CTH), TaiwanJung-Fu Chen, M.D., Principal investigator, Chang Gung Memorial Hospital- Kaoshiung, TaiwanChien-Wen Chou, M.D., Principal investigator, Chi-Mei Medical Center, Tainan, TaiwanChe-Han Hsu, M.D., Principal investigator, Cheng Ching Hospital, Taichung, TaiwanJoseph De Santo, M.D., Principal investigator, HealthCare Partners, Pasadena, USALee Rogers, M.D., Principal investigator, The Amputation Prevention Center at Broadlawns Medical Center, Des Moines, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685698
- Sponsor's protocol ID
- TG-873870-04
- Status last verified
- Dec 2014
- First submitted
- 22 May 2008
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multi-Center Study of TG-873870 for Treating Patients With Diabetic Foot Infections of Mild to Moderate Severity Associated With Gram-Positive Pathogens
- ClinicalTrials.gov ID
- NCT00685698
- Acronym / sponsor ID
- TG-873870-04
- Conditions
- Diabetic Foot Infections
- Keywords
- Diabetic Foot Infections, DFI, Nemonoxacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections
Detailed description
This study will assess the safety and efficacy of TG-873870 (Nemonoxacin) in patients with Diabetic Foot Infections. Pharmacokinetic (PK) and pharmacodynamic (PD) assessment will be conducted in a subgroup of eight consenting patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nemonoxacin | Other | Drug: TG-873870 (Nemonoxacin)Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body weight ≥ 40 kg
- Previously known or newly diagnosed diabetes mellitus, including type 1 and type 2 (per the American Diabetes Association guidelines), which is controlled by proper lifestyle (diet, exercise) or treatment with either oral medications or insulin
- Patients' HbA1c ≦ 12% at screening
- Clinically defined diabetic foot infection of mild or moderate severity (PEDIS grade 2-3) as based on the guideline of the Infectious Diseases Society of America. It includes any inframalleolar infection of the soft-tissue, such as paronychia, cellulitis, myositis, abscesses, and tendonitis
- Evidence of necrotic tissue, purulent collections or abscess that may require excision, incision or drainage (based on investigator's judgment, and a surgeon if needed)
Key exclusion criteria (12 listed)
- A co-morbid disease condition that could compromise evaluation or participation in this study, such as severe hepatic disease (e.g., active hepatitis, decompensated liver cirrhosis), renal failure (estimated creatinine clearance [CrCl] <30 ml/minute or need for hemodialysis or peritoneal dialysis), or active systemic malignancy (advanced or metastatic), unless enrollment is deemed appropriate at the discretion of the Investigator with prior consultation with the study Medical Monitor
- History of prolonged QTc interval or a medical condition requiring the use of a concomitant medication that is associated with an increased QTc interval (e.g., class I or class III anti-arrhythmic agents)
- Contact dermatitis over the infected skin area, infected third-degree burn wounds, necrotizing fascitis, extensive gangrene, pyoderma gangrenosum, deep vein thrombosis, shock, or any medical disorder that could either interfere with the evaluation of treatment or the response of the patient to therapy
- Radiological evidence of bone or joints infection within 7 days prior to or at screening, i.e. potential osteomyelitis or septic arthritis
- Clinically defined uninfected or severe infection (PEDIS grade 1 or 4) as based on the Infectious Diseases Society of America classification system
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 |
|---|---|---|
| TG-873870 (Nemonoxacin)Also: Taigexyn750 mg | Drug | Nemonoxacin |
Primary outcome
Clinical Success (in ITT Population)
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Clinical Success * Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection. * Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions.
18 secondary outcomes
Microbiological Success Rate
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Clinical Success (in PP Population)
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Clinical Success (at End of Treatment/Early Termination)
Time frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Per-Pathogen Clinical Responses (at Test of Cure)
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Per-Pathogen Clinical Response (at End of Treatment/Early Termination)
Time frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Per-Pathogen Microbiological Responses
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Total Wound Score (at Test of Cure in ITT Population)
Time frame: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Total Wound Score (at Test of Cure in PP Population)
Time frame: Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Total Wound Score (at End of Treatment/ Early Termination in ITT Population)
Time frame: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Total Wound Score (at End of Treatment/ Early Termination in PP Population)
Time frame: Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population
Time frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population
Time frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)
Time frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)
Time frame: End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)
Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)
Time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kuang-Chung Shih, M.D. study chair
Tri-Service General Hospital, Taipei, Taiwan
Jawl-Shan Hwang, M.D. principal investigator
Cheng-Gung Memorial Hospital - LinKou, Taiwan
Te-Lin Hsia, M.D. principal investigator
Cardinal Tien Hospital (CTH), Taiwan
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TG-873870 (Nemonoxacin) in people with Diabetic Foot Infections, run by TaiGen Biotechnology Co., Ltd. at 16 sites in 4 countries.
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 12 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: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Taiwan, South Africa, United States, Thailand. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (in ITT Population) (time frame: Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination). 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 1 Jul 2025.