An interventional study of Compression therapy and initial clinical assessment in Lower Limb Cellulitis, sponsored by University Hospital Plymouth NHS Trust. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by University Hospital Plymouth NHS Trust · Not applicable, Interventional, and Treatment
Initiating early compression therapy in the treatment of lower limb cellulitis for adults admitted to the acute hospital to improve patient outcomes - a pilot study
Cellulitis is a skin infection that results in oedema (additional fluid within tissues), erythema (redness) and variable levels of skin damage. Patients generally present with malaise, pain and if a lower limb is affected they have difficulty mobilising and weight bearing. Patients within this organisation are often referred to the tissue viability service only after significant skin damage has occurred (even thought they are receiving appropriate antibiotic therapy). At this point they will be offered an established plan of care that includes compression therapy if it can be tolerated however at present less than 50% of those being admitted are referred.
Despite compression therapy being well proven in oedema management there is no data available to support or reject the early application in lower limb cellulitis. There is also a lack of information about the impact of early intervention in quality of life for patients in this specific group.
This study has been developed in order to determine the feasibility of being able to undertake a wider trial which would evaluate the outcomes of patients with acute lower limb cellulitis treated with compression therapy versus standard care.
The objectives of the study would be to test the procedures and data collection tools being considered for use in a wider study. This would include collection of quality outcome questionnaires, limb circumference measurements and photography as well as recruitment of participants, the follow up processes and participant attrition. Secondary objectives would be linked to quality of life outcome measures and would determine oedema reduction (and its impact on quality of life), the average number of beddays compared to a historical cohort and to determine recurrence within the study period.
Cellulitis is a skin infection that results in oedema (additional fluid within tissues), erythema (redness) and variable levels of skin damage. Patients generally present with malaise, pain and if a lower limb is affected they have difficulty mobilising and weight bearing. Patients within this organisation are often referred to the tissue viability service only after significant skin damage has occurred (even thought they are receiving appropriate antibiotic therapy). At this point they will be offered an established plan of care that includes compression therapy if it can be tolerated however at present less than 50% of those being admitted are referred.
Despite compression therapy being well proven in oedema management there is no data available to support or reject the early application in lower limb cellulitis. There is also a lack of information about the impact of early intervention in quality of life for patients in this specific group.
This study has been developed in order to determine the feasibility of being able to undertake a wider trial which would evaluate the outcomes of patients with acute lower limb cellulitis treated with compression therapy versus standard care.
The objectives of the study would be to test the procedures and data collection tools being considered for use in a wider study. This would include collection of quality outcome questionnaires, limb circumference measurements and photography as well as recruitment of participants, the follow up processes and participant attrition. Secondary objectives would be linked to quality of life outcome measures and would determine oedema reduction (and its impact on quality of life), the average number of beddays compared to a historical cohort and to determine recurrence within the study period.
147 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 2 is below the median of 157 across 118 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
compression therapy
Other: Compression therapy · Diagnostic Test: initial clinical assessment
standard treatment
Diagnostic Test: initial clinical assessment
Compression application
Initial clinical assessment (includes history, vascular assessment, limb examination and wound assessment where necessary)
Recruiting 40 participants within 6 months
Recruitment of 40 participants within 6 months, who meet the eligibility criteria
Time frame: 6 months
Determine changes in quality of life outcome measures using EQ-5D-5L questionnaires.
Quality of life outcome measures analysing EQ-5D-5L questionnaires.
Time frame: 6 months
Determine oedema reduction.
Measuring limb circumference sequentially to estimate limb volume at each bandage change. Measurement in centimetres.
Time frame: 6 months
Determine average number of bed days.
Comparing historical cohort of 40 patients admitted for treatment from April 2017
Time frame: 6 months
To determine cellulitis recurrence in patients within the study period.
To record cellulitis recurrence in the 40 patients admitted for treatment from April.
Time frame: 6 months
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University Hospital Plymouth NHS Trust