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Diabetic Foot InfectionNCT04714411

Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

An observational study of Diabetic Foot Infection, run by Methodist Health System at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Infection
What is being tested?
Omadacycline
How many people
42 participants
Where
2 sitesUnited States
Study dates
5 Nov 2020to 14 Jul 2025
Phase
Observational
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

Study population: Adult diabetic with DFI hospitalized, 18 years or older, diagnosed with type 1 or 2 diabetes, and have DFI with or without AOM

Who may be able to join

  • Female and male subjects will be eligible for inclusion if hospitalized, 18 years or older, diagnosed with type 1 or 2 diabetes, and have DFI with the additional clinical criteria as specified below:
  • Acute infection or worsening without systemic antimicrobials within the previous 14 days
  • At least one full or partial thickness-infected ulcer at or below the ankle AND
  • Purulent drainage OR
  • Two of the following:
  • Erythema
Show all 20Show fewer
  • Local edema
  • Fluctuance
  • Induration
  • Increased local warmth
  • Fever
  • No systemic antimicrobials with current hospital admission for more than 48 hours prior to enrollment
  • Empiric coverage based on organisms suspected to be caused by susceptible bacteria, if no culture identifies a specific organism; or
  • Confirmed susceptibility to omadacycline against any organism identified. Any subject in which a pathogen resistant to omadacycline is identified will be excluded from the study and antibiotics will be changed based on physician discretion.
  • First episodes of AOM at qualifying site of infection will be eligible for inclusion with any of the following criteria confirming the diagnosis:
  • Imaging (X-ray or MRI) confirmation of acute osteomyelitis
  • Pathology (bone biopsy/culture)
  • Not currently enrolled in any other clinical trial
  • Provides informed consent
  • Likely to be compliant with all study-related procedures and visits

Who cannot join

  • Age less than 18 years
  • Pregnant women
  • Chronic osteomyelitis
  • Osteomyelitis of the same site previously treated with antibiotics
  • Documented presence of osteomyelitis more than 2 weeks prior to index admission
  • Necrotic or dead bone identified by pathology
Show all 12Show fewer
  • Unclear chronicity of infection (if unable to determine acute osteomyelitis)
  • Has any gangrenous ulcers or necrotizing fasciitis
  • Has a pathogen known to be resistant to omadacycline
  • Administration of additional systemic antibiotics in combination with omadacycline, not including topical routes or oral vancomycin/fidaxomicin given their local activity within the GI tract
  • Contraindication or hypersensitivity to omadacycline/tetracyclines
  • Unwilling or unable to participate in study-related procedures or visits

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Methodist Charlton Medical Center

    Dallas, Texas, 75237

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Omadacycline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmadacyclineDrug

    Omadacycline monotgherapy

Study groups in NCT04714411
Study groupRoleWhat they receive
Retrospective CohortA historical matched case cohort
Prospective CohortSubjects will be screened daily via review of the EMR reports of inpatient admissions. Those receiving antibiotics with a notated source of skin/soft tissue infection or OM will be further reviewed to determine if the source of infection is a DFI with or without suspected or confirmed Acute osteomyelitis.
Receives: Drug: Omadacycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AKI based on RIFLE criteria

    Risk, injury, failure, loss and ESRD

    Measured: Sept 2020 - Aug 2021

  2. Clostridioides difficile Infection

    Frequency of Clostridioides difficile Infections while taking Omadacycline compared to other antibiotics

    Measured: Sept 2020 - Aug 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2021
  2. Study start5 Nov 2020
  3. Primary completion14 Jul 2025
  4. Study completion14 Jul 2025

Resources

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04714411
Sponsor's protocol ID
014.PHA.2020.A
Status last verified
Mar 2026
First submitted
14 Jan 2021
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • National Center for Health Statistics (US). Health, United States, 2016: With Chartbook on Long-term Trends in Health. Hyattsville (MD): National Center for Health Statistics (US); 2017 May. Report No.: 2017-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK453378/

    PubMed 28910066

  • Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

    PubMed 15111519

  • Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.

    PubMed 15644549

  • Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Tennvall GR, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, Van Baal J, Van Merode F, Schaper N. Optimal organization of health care in diabetic foot disease: introduction to the Eurodiale study. Int J Low Extrem Wounds. 2007 Mar;6(1):11-7. doi: 10.1177/1534734606297245.

    PubMed 17344196

  • Lazaro Martinez JL, Garcia Alvarez Y, Tardaguila-Garcia A, Garcia Morales E. Optimal management of diabetic foot osteomyelitis: challenges and solutions. Diabetes Metab Syndr Obes. 2019 Jun 21;12:947-959. doi: 10.2147/DMSO.S181198. eCollection 2019.

    PubMed 31417295

  • Johnson MJ, Shumway N, Bivins M, Bessesen MT. Outcomes of Limb-Sparing Surgery for Osteomyelitis in the Diabetic Foot: Importance of the Histopathologic Margin. Open Forum Infect Dis. 2019 Sep 10;6(10):ofz382. doi: 10.1093/ofid/ofz382. eCollection 2019 Oct.

    PubMed 31660346

  • Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1.

    PubMed 24186882

  • Crotty MP, Akins RL, Alexander JS, Alexander NT, Dominguez EA. Clinical Experience with Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis. Infect Dis Ther. 2026 Oct 6. doi: 10.1007/s40121-026-01450-0. Online ahead of print.

    PubMed 42836951

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Foot Infection, run by Methodist Health System at 2 sites in United States.

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 20 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

AKI based on RIFLE criteria (time frame: Sept 2020 - Aug 2021). The study lists 2 primary outcomes in all. 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 NCT04714411, which also lists 8 linked publications.

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 27 Mar 2026.

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