Lower Limb Cellulitis Clinical Trial
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
| NCT number | NCT04272814 |
| Other study ID # | 17/P/203 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 11, 2018 |
| Est. completion date | April 4, 2019 |
| Verified date | February 2020 |
| Source | University Hospital Plymouth NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | April 4, 2019 |
| Est. primary completion date | April 4, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Derriford Hospital | Plymouth |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Plymouth NHS Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recruiting 40 participants within 6 months | Recruitment of 40 participants within 6 months, who meet the eligibility criteria | 6 months | |
| Secondary | Determine changes in quality of life outcome measures using EQ-5D-5L questionnaires. | Quality of life outcome measures analysing EQ-5D-5L questionnaires. | 6 months | |
| Secondary | Determine oedema reduction. | Measuring limb circumference sequentially to estimate limb volume at each bandage change. Measurement in centimetres. | 6 months | |
| Secondary | Determine average number of bed days. | Comparing historical cohort of 40 patients admitted for treatment from April 2017 | 6 months | |
| Secondary | To determine cellulitis recurrence in patients within the study period. | To record cellulitis recurrence in the 40 patients admitted for treatment from April. | 6 months |