Compression Therapy for Acute Lower Limb Cellulitis
Primary Purpose
Lower Limb Cellulitis
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Compression therapy
initial clinical assessment
Sponsored by
About this trial
This is an interventional treatment trial for Lower Limb Cellulitis
Eligibility Criteria
Inclusion Criteria:
- Clinical features of acute class 2-4 cellulitis of the lower leg
- They have an Ankle Brachial Pressure Index between ≥0.8 and ≤1.3 or Toe Brachial Pressure Index ≥ 0.7 for treatment with full compression therapy
- They have a Laboratory Risk Indicator for Necrotising Fasciitis (LRINEC) score of less than 6 and no clinical signs of necrotising fasciitis
- They are able to tolerate compression therapy, keeping the bandages in place above the level of visible cellulitis for the treatment period
- 18 years or older capable of giving informed consent
- They are admitted to the study setting
Exclusion Criteria:
- Clinical signs or symptoms of peripheral arterial disease
- Unable to give informed consent
- Unable/unwilling to wear compression bandages for study period
Sites / Locations
- Derriford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Compression therapy
Standard treatment
Arm Description
compression therapy
standard treatment
Outcomes
Primary Outcome Measures
Recruiting 40 participants within 6 months
Recruitment of 40 participants within 6 months, who meet the eligibility criteria
Secondary Outcome Measures
Determine changes in quality of life outcome measures using EQ-5D-5L questionnaires.
Quality of life outcome measures analysing EQ-5D-5L questionnaires.
Determine oedema reduction.
Measuring limb circumference sequentially to estimate limb volume at each bandage change. Measurement in centimetres.
Determine average number of bed days.
Comparing historical cohort of 40 patients admitted for treatment from April 2017
To determine cellulitis recurrence in patients within the study period.
To record cellulitis recurrence in the 40 patients admitted for treatment from April.
Full Information
NCT ID
NCT04272814
First Posted
January 15, 2018
Last Updated
February 14, 2020
Sponsor
University Hospital Plymouth NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04272814
Brief Title
Compression Therapy for Acute Lower Limb Cellulitis
Official Title
Initiating Early Compression Therapy in the Treatment of Lower Limb Cellulitis for Adults Admitted to the Acute Hospital to Improve Patient outcomes-a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
The patient pathway changed resulting in less admissions for this condition.
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
April 4, 2019 (Actual)
Study Completion Date
April 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Plymouth NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Cellulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
compression therapy vs standard therapy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compression therapy
Arm Type
Experimental
Arm Description
compression therapy
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
standard treatment
Intervention Type
Other
Intervention Name(s)
Compression therapy
Intervention Description
Compression application
Intervention Type
Diagnostic Test
Intervention Name(s)
initial clinical assessment
Intervention Description
Initial clinical assessment (includes history, vascular assessment, limb examination and wound assessment where necessary)
Primary Outcome Measure Information:
Title
Recruiting 40 participants within 6 months
Description
Recruitment of 40 participants within 6 months, who meet the eligibility criteria
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determine changes in quality of life outcome measures using EQ-5D-5L questionnaires.
Description
Quality of life outcome measures analysing EQ-5D-5L questionnaires.
Time Frame
6 months
Title
Determine oedema reduction.
Description
Measuring limb circumference sequentially to estimate limb volume at each bandage change. Measurement in centimetres.
Time Frame
6 months
Title
Determine average number of bed days.
Description
Comparing historical cohort of 40 patients admitted for treatment from April 2017
Time Frame
6 months
Title
To determine cellulitis recurrence in patients within the study period.
Description
To record cellulitis recurrence in the 40 patients admitted for treatment from April.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical features of acute class 2-4 cellulitis of the lower leg
They have an Ankle Brachial Pressure Index between ≥0.8 and ≤1.3 or Toe Brachial Pressure Index ≥ 0.7 for treatment with full compression therapy
They have a Laboratory Risk Indicator for Necrotising Fasciitis (LRINEC) score of less than 6 and no clinical signs of necrotising fasciitis
They are able to tolerate compression therapy, keeping the bandages in place above the level of visible cellulitis for the treatment period
18 years or older capable of giving informed consent
They are admitted to the study setting
Exclusion Criteria:
Clinical signs or symptoms of peripheral arterial disease
Unable to give informed consent
Unable/unwilling to wear compression bandages for study period
Facility Information:
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Compression Therapy for Acute Lower Limb Cellulitis
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