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

Prospective, single-centre, cohort study assessing the potential application of WOUNDCHEK™ diagnostics for ulcer management

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11300898

Enrollment

129

Registered

2023-07-17

Start date

2023-02-01

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic ulcer wounds of the legs and feet Skin and Connective Tissue Diseases

Interventions

Written informed consent will be taken from the patients. Patients will be in the study for 12 weeks, with outcome measures being taken at week0 week6, and week12. At week0 and week6, their ulcer will

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026