Compression Therapy for Acute Lower Limb Cellulitis

NCT04272814 | Terminated

• 1 other identifier: 17/P/203
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Cellulitis

Outcome Measures

Primary Outcomes (1)

• Recruiting 40 participants within 6 months

  Recruitment of 40 participants within 6 months, who meet the eligibility criteria

  6 months

Secondary Outcomes (4)

• Determine changes in quality of life outcome measures using EQ-5D-5L questionnaires.

  6 months

• Determine oedema reduction.

  6 months

• Determine average number of bed days.

  6 months

• To determine cellulitis recurrence in patients within the study period.

  6 months

Study Arms (2)

Compression therapy

EXPERIMENTAL

compression therapy

Other: Compression therapy; Diagnostic Test: initial clinical assessment

Standard treatment

ACTIVE COMPARATOR

standard treatment

Diagnostic Test: initial clinical assessment

Interventions

Compression therapy OTHER

Compression application

Compression therapy

initial clinical assessment DIAGNOSTIC_TEST

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

Compression therapy; Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older capable of giving informed consent
• They are admitted to the study setting

You may not qualify if:

• Clinical signs or symptoms of peripheral arterial disease
• Unable to give informed consent
• Unable/unwilling to wear compression bandages for study period

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Derriford Hospital

Plymouth, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: compression therapy vs standard therapy

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 17, 2020
• Study Start: July 11, 2018
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

GB (1)