Evaluation of the WOUNDCHEK point-of-care test for infection in the management of foot and leg ulcers

Not Applicable

Completed

• Conditions: Chronic ulcer wounds of the legs and feet; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN11300898
• Lead Sponsor: orth Cumbria Integrated Care NHS Foundation Trust

Brief Summary

2024 Results article in https://doi.org/10.1177/15347346241284804 (added 25/09/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-17
• Study Completion: 2024-05-30
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

1. Adult patients aged > = 18 years
2. Patients can be newly presenting to or existing users of the specialist service in question (eg podiatry, vascular surgery)
3. Patients with recurrent wounds, including multiple wounds, are eligible; largest ulcer to be index wound
4. If infection occurs and antibiotics applied, whilst in study, then this is not deemed an exclusion criterion.
5. Prophylactic systemic antibiotic use is not an exclusion criterion
6. Chronicity: clinical diagnosis of ulcer with wound duration > 30 days.
7. Wound type:
7.1. Leg ulcer (can be venous, mixed or arterial in nature)
7.2. Foot ulcer (can be diabetic or non-diabetic in nature)

Exclusion Criteria

1. Aged < 18 years
2. Any reasons for the patient being unable to follow the protocol, including lack of mental capacity to consent to taking part in the study.
3. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives
4. Confirmed and ongoing wound infection at baseline which is already being treated with systemic antibiotics.
5. Previous participation in BIOME study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. WOUNDCHEK test for presence of wound infection is done at weeks 0 and 6.2. General quality of life questionnaire (EQ-5D-5L) is done at weeks 0, 6, and 12.3. Ulcer related pain (visual display scale) is measured at weeks 0, 6, and 12.4. Ulcer is assessed – as long as its still present – for characteristics like purulence, erythema and odour at weeks 0,6, and 12.5. Wound size is measured with validated PUSH score at weeks 0, 6 , and 12.6. Any deviation from original clinical treatment plan (due to WOUNDCHEK result) is recorded at weeks 0 and 6.

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures