Diabetic Foot Infection Clinical Trial
Official title:
Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis
This will be a prospective, open-label, two-center study to assess the safety of omadacycline use in the treatment of hospitalized subjects with moderate to severe DFI with or without Acute osteomyelitis (AOM) who are at a high risk for development of CDI, AKI, and/or resistant pathogens compared to retrospective controls. Prospective enrollment will be continued until the sample size is achieved up to one year from start date (October 2020). Secondary to slower than anticipated enrollment due to the COVID-19 pandemic and initial exclusion of AOM, following protocol amendment, patient enrollment will be continued until the sample size is achieved up to 18 months from amendment approval (anticipate April 2022 - October 2023). A historical matched case cohort (standard of care) at the two hospitals based on ICD10 codes associated with DFI [E11.(621, 622), E10.(621, 622); L97.(509, 521, 522, 523, 524, 529)], including subjects with AOM [M86.(08-09, 10, 16-19, 8X0, 8X7-8X9, 9) will be utilized for comparison.
This is a year-long study with planned enrollment of 57 patients (in addition to 114 historical control patients) evaluating the use of omadacycline for treatment of diabetic foot infections (DFI). Omadacycline (Nuzyra®) is a FDA approved antibiotic for skin and skin structure infection and community-acquired pneumonia. This study is considered to be investigational because data is being collected on the use of Omadacycline for the treatment of DFI with or without AOM. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
| Recruiting |
NCT05613985 -
PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers
|
N/A | |
| Recruiting |
NCT03964571 -
Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients
|
N/A | |
| Completed |
NCT03230175 -
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
|
Phase 2 | |
| Completed |
NCT05616351 -
Antibiotic Therapy in Infections of the Diabetic Foot Syndrome
|
||
| Recruiting |
NCT05948592 -
Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection
|
Phase 2 | |
| Completed |
NCT05243810 -
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
|
N/A | |
| Recruiting |
NCT04450693 -
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
|
Phase 3 | |
| Recruiting |
NCT05610865 -
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
|
Phase 1 | |
| Recruiting |
NCT05369052 -
Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
|
Phase 3 | |
| Completed |
NCT02723539 -
A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI
|
Phase 1 | |
| Completed |
NCT04440839 -
Implementation of Telemedicine for Patient With Lower Extremity Wounds
|
N/A | |
| Withdrawn |
NCT04289948 -
Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes
|
Phase 1/Phase 2 | |
| Completed |
NCT03495349 -
Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.
|
||
| Completed |
NCT05564728 -
Diabetes Footcare Companion App for Patients and Carers
|
||
| Withdrawn |
NCT03354806 -
Peripheral Analgesia in Painful Diabetic Neuropathy
|
N/A | |
| Completed |
NCT01594762 -
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
|
Phase 3 | |
| Completed |
NCT01590758 -
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
|
Phase 3 | |
| Active, not recruiting |
NCT05174806 -
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
|
Phase 2 | |
| Recruiting |
NCT04141787 -
Ceftriaxone as Home IV for Staph Infections
|
Phase 4 |