Compression Therapy for Acute Lower Limb Cellulitis

NCT ID: NCT04272814

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2019-04-04

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.

Conditions

Lower Limb Cellulitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Compression therapy

compression therapy

Group Type: EXPERIMENTAL

Compression therapy

Intervention Type: OTHER

Compression application

initial clinical assessment

Intervention Type: DIAGNOSTIC_TEST

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

Standard treatment

standard treatment

Group Type: ACTIVE_COMPARATOR

initial clinical assessment

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Compression therapy

Compression application

Intervention Type: OTHER

initial clinical assessment

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Derriford Hospital

Plymouth, , United Kingdom

Countries

United Kingdom

Other Identifiers

17/P/203

Identifier Type: -

Identifier Source: org_study_id