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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
University Hospital Plymouth NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Cellulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 15, 2018
Last Updated
February 14, 2020
Sponsor
University Hospital Plymouth NHS Trust
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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

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Compression Therapy for Acute Lower Limb Cellulitis

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