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Compression Therapy for Acute Lower Limb Cellulitis

NCT04272814 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Lower Limb Cellulitis

Interventions

OTHER

Compression therapy

Compression application

DIAGNOSTIC_TEST

initial clinical assessment

Initial clinical assessment (includes history, vascular assessment, limb examination and wound assessment where necessary)

Sponsors & Collaborators

  • University Hospital Plymouth NHS Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2019-04-04
Completion
2019-04-04

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272814 on ClinicalTrials.gov