An observational study in Cellulitis, Cellulitis of Leg and Antibiotic Duration, sponsored by University of Sussex. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by University of Sussex · Observational
Cellulitis is an increasingly common and unpleasant bacterial infection of the skin, usually affecting the legs. Patients experience pain and swelling, loss of mobility, fever, and chills. Patients may be left with chronic skin damage and 1 in 5 experience recurrences.
Cellulitis is treated with antibiotics, but it is unclear as to how long treatment should be for. As a result, many patients get much longer antibiotic treatment than needed. This exposes patients to the risks of taking unnecessary antibiotics.
This study aims to find out what features of individual patients predict a good, sustained recovery from cellulitis. These may include medical conditions and clinical response to the first few days of antibiotic treatment, such as changes in skin temperature.
Patients who are being treated in hospital for cellulitis will be invited to take part. Information will be collected about patients who will be followed up for 3-6 months. Devices for measuring skin temperature will also be compared to see which one works best. This information will be used to help develop a set of rules that doctors can use to guide the length of antibiotic treatment. This should ensure that future patients receive the amount of antibiotics needed and no more.
This study is a single centre prospective cohort study of patients with cellulitis of the lower limb. The primary objective of this study is to understand what features of individual patients predict a sustained recovery from cellulitis. This information will be used to test and refine a previously developed risk score that predicts clinical outcomes of patients with cellulitis.
Secondary objectives include investigating whether early response to antibiotic treatment (e.g. reduction in skin temperature and patient-reported symptoms) improves the predictive ability of the risk score. The study design also includes a nested technology comparison of temperature measurement devices to identify the best device for measuring affected skin temperature change in patients with cellulitis.
Clinical response will be measured for up to four days from starting antibiotic treatment. This includes the change in temperature and area of affected skin, physiological observations, blood test results (e.g. C-reactive protein) and patient-reported pain and swelling scores. Patients will be followed up at 28 and 90 days (+/- 180 days for those recruited in the first year) to assess recovery, recurrence, cellulitis-related mortality, quality of life, and return to normal activities.
160 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 230 is above the median of 208 across 29 observational studies indexed under Cellulitis.
Browse Cellulitis studies →University of Sussex is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospital-based or services delivering antibiotic treatment and ongoing follow-up regardless of location.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults (age ≥18 years) identified by their treating clinician as having lower limb cellulitis that requires intravenous or oral antibiotic treatment either from the hospital or another service based outside of the hospital, which will conduct ongoing follow-up regardless of location.
Sustained Recovery
Number of Participants with Sustained Recovery
Time frame: 90 days
Cellulitis-related Readmission
Number of participants with new hospital admission/reattendance containing a cellulitis diagnostic code
Time frame: 90 days
Recovery at 28 Days
Number of participants who recovered within 28 days (investigator assessed)
Time frame: 28 days
Patient-reported Recovery by 28 Days
Number of patients recovered within 28 days (patient-reported)
Time frame: 28 days
Time to Return to Work / Normal Activities
Number of patients who reported they had returned to work / normal activities within 90 days
Time frame: Baseline to 90 days
Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)
The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health.
Time frame: Baseline to 90 days
Change in Mental Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12)
The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health.
Time frame: Baseline to 90 days
Repeatability Coefficient
Repeatability, defined as the consistency of measurements when taken repeatedly at short intervals by the same device under the same conditions, was assessed by calculating the repeatability coefficient. The repeatability coefficient and estimated 95% Confidence Interval were calculated from one temperature measurement and an instant repeated temperature measurement of the limb of interest on each participant on days 0, 1, 2, 3, all combined. The repeatability coefficient can be interpreted as the range (between the negative and positive values of the coefficient) within which the difference between any two repeated measurements on the same subject is expected to lie for 95% of subjects.
Time frame: Measurements taken at 0 to 3 days
Limits of Agreement
The mean represents the estimated mean difference in affected-limb temperature between measurement methods; the reported 95% interval corresponds to the limits of agreement.
Time frame: Measurements taken at 0 to 3 days
230 recruited: * 13 excluded * 10 died within 90 days before recurrence * 4 withdrew * 1 loss to follow-up 202 included in final analysis
| Milestone | Cohort |
|---|---|
| Started | 230 |
| Completed | 202 |
| Not completed | 28 |
| Withdrew: Protocol violation | 13 |
| Withdrew: Death | 10 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 1 |
Number of Participants with Sustained Recovery
| Participants | Cohort |
|---|---|
| Sustained Recovery | 156 |
Number of participants with new hospital admission/reattendance containing a cellulitis diagnostic code
| Participants | Cohort |
|---|---|
| Cellulitis-related Readmission | 17 |
Number of participants who recovered within 28 days (investigator assessed)
| Participants | Main Cohort |
|---|---|
| Recovery at 28 Days | 70 |
Number of patients recovered within 28 days (patient-reported)
| Participants | Cohort |
|---|---|
| Patient-reported Recovery by 28 Days | 72 |
Number of patients who reported they had returned to work / normal activities within 90 days
| Participants | Cohort |
|---|---|
| Time to Return to Work / Normal Activities | 125 |
The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health.
| Scores on a scale | Cohort |
|---|---|
| Change in Physical Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) | 8.0 (6.1 to 9.8) |
The Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) comprises a Physical Component Summary and a Mental Component Summary, each reported as norm-based scores (mean 50, SD 10; range 0-100), where higher values indicate better physical or mental health.
| Scores on a scale | Cohort |
|---|---|
| Change in Mental Component Score Assessed Using the Medical Outcomes Study Short Form 12-Item Health Survey (SF-12) | 2.5 (0.5 to 4.4) |
Repeatability, defined as the consistency of measurements when taken repeatedly at short intervals by the same device under the same conditions, was assessed by calculating the repeatability coefficient. The repeatability coefficient and estimated 95% Confidence Interval were calculated from one temperature measurement and an instant repeated temperature measurement of the limb of interest on each participant on days 0, 1, 2, 3, all combined. The repeatability coefficient can be interpreted as the range (between the negative and positive values of the coefficient) within which the difference between any two repeated measurements on the same subject is expected to lie for 95% of subjects.
| Repeatability coefficient | Cohort |
|---|---|
| Repeatability Coefficient | 0.68 (0.61 to 0.75) |
Repeatability, defined as the consistency of measurements when taken repeatedly at short intervals by the same device under the same conditions, was assessed by calculating the repeatability coefficient. The repeatability coefficient and estimated 95% Confidence Interval were calculated from one temperature measurement and an instant repeated temperature measurement of the limb of interest on each participant on days 0, 1, 2, 3, all combined. The repeatability coefficient can be interpreted as the range (between the negative and positive values of the coefficient) within which the difference between any two repeated measurements on the same subject is expected to lie for 95% of subjects.
| Repeatability coefficient | Cohort |
|---|---|
| Repeatability Coefficient | 0.82 (0.75 to 0.90) |
The mean represents the estimated mean difference in affected-limb temperature between measurement methods; the reported 95% interval corresponds to the limits of agreement.
| Degrees celsius | Cohort |
|---|---|
| Limits of Agreement | -2.52 (-5.47 to 0.43) |
Collected over Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort | — | — | — |
| Age, Continuous(Years) | Cohort |
|---|---|
| Median | 66 (51 to 79) |
| Sex: Female, Male(Participants) | Cohort |
|---|---|
| Female | 84 |
| Male | 118 |
| Race/Ethnicity, Customized(Participants) | Cohort |
|---|---|
| White ethnicity | 191 |
| Non-white ethnicity | 3 |
| Missing | 8 |
| Patient-reported previous cellulitis(Participants) | Cohort |
|---|---|
| Count of participants | 105 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymised study data is intended to be made available via an open access research database.
Ran from Jun 2021 to primary completion in Jun 2023, 23 months.
Results were first posted in Mar 2026, 2 years 9 months after primary completion.
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of Sussex