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Trial · NCT05584007

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPain assessmentDays 7-16Self-reported pain (measured using the Pain Numeric Rating Scale (0-10))
SecondaryUse of additional antibioticsUp to day 28Any reported use of antibiotics other than the initial 5 days of flucloxacillin and 2 days of IMP)
SecondaryPatient-reported assessment of how well they are feelingDays 6-14Numeric rating scale NRS (0-10) and assessed as repeated measures
SecondaryHealth related quality of lifeDays 6-14EQ-5D-5L - values, and individual dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) level scores using repeated measures.
SecondaryHealth related quality of life used to estimate Quality Adjusted- Life Years (QALYs)Days 6-14EQ-5D-5L - values, and individual dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) level scores using repeated measures.
SecondaryLeg swelling and warmthDay 7, 14, 21, 28Participant reported questionnaire
SecondaryTime until self-reported recoveryDay 7, 14, 21, 28Participant reported questionnaire
SecondaryTime until self-assessed extent of cellulitis starts to reduce (with no subsequent increase)Day 7, 14, 21, 28Participant reported questionnaire
SecondaryHospital admissions12 monthsNumber of hosptial admissions since randomisation, collected from primary care notes review
SecondaryRecurrent cellulitis episodes over 12 months (number of episodes)12 monthsRecurrent cellulitis episodes over 12 months (number of episodes) since randomisation, collected from primary care notes review
SecondaryComplications over 12 months12 monthsNumber of reported complications since randomisation, collected from primary care notes review

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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