Wound Infection Detection Evaluation, WIDE

NCT03883230 | Completed

• 1 other identifier: CP1713
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic wounds, such as diabetic foot ulcers, place a huge burden on healthcare systems and can lead to complications with high morbidity, particularly if the wound if infected. In parallel, there is pressure to reduce the use of antibiotics in order to minimise the risk of antimicrobial resistance. The Glycologic wound detection kit (GLYWD) is a point-of-care test, designed to provide guidance to clinical staff as to whether a chronic wound is infected or not. In this prospective cohort study the premise of this mode-of-action is evaluated. GLYWD will be applied in conjunction with clinical opinion and microbiological testing to determine if there is concordance between the different diagnostic approaches, and if applicable how they may differ in certain patients' wounds.

Conditions

Wound Infection Bacterial; Ulcer Foot; Diabetic Foot; Diagnostic Self Evaluation

Outcome Measures

Primary Outcomes (1)

• GLYWD test result

  Result of diagnostic testing of wound with GLYWD

  10 minutes

Secondary Outcomes (2)

• Microbiology result of wound swab

  2 days

• Clinician's wound characterization

  1 minute

Study Arms (1)

Patients with chronic wound

All patients will have a Glycologic infection detection test (GLYWD) taken. For this, a standard CE-marked sterile swab is used to take a wound exudate sample. This is then inserted in the GLYWD detection tube device. The device will contain two separate reagents, one in the clear plastic vial end and the other in the foil-sealed compartment. The sterile swab with the wound exudate sample will be pushed into the device, breaking the foil-sealed compartment and allowing the reagents to mix with the sample. the result of the test - to see if there is a bacterial infection present in the wound - is observed up to ten minutes later.

Diagnostic Test: GLYWD

Interventions

GLYWD DIAGNOSTIC_TEST

As mentioned in the group description, GLYWD is a plastic test tube and a chromatic test that contains two solutions. When combined with a wound exudate and incubated at RT, it will change colour to red if there is a pathological bacterial wound infection present.

Patients with chronic wound

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic non-infected Diabetic Foot Ulcers (DFU) or other chronic and delayed-healing wounds will be recruited into the study. Patients will be recruited from the adult population seen routinely by the evaluation clinical staff.

You may qualify if:

• \- Adult patients aged \> 18 years
• Patients with recurrent wounds, including multiple wounds, are eligible (including patients who have concluded participation in this study for one wound, but have another wound in another location).
• DFU element: Clinical diagnosis of Diabetic Foot Ulcer (DFU) with wound duration \> 30 days.
• Other Other chronic and delayed-healing wounds element: Clinical diagnosis of a chronic or delayed-healing wound, with the wound present for at least 6 weeks. To include:
• Pressure ulcer
• Leg ulcer (can be venous, mixed or arterial in nature)
• Non-diabetic foot ulcer
• Post-operative wound
• Trauma or other non-surgical wounds

You may not qualify if:

• \- Aged \< 18 years
• Any reasons for the patient being unable to follow the protocol, including lack of mental capacity to consent to taking part in the study.
• The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives
• DFU element only:
• Confirmed and ongoing wound infection at baseline which is already being treated with systemic antibiotics.

Sponsors & Collaborators

• Cumbria Partnership NHS Foundation Trust: lead

Study Sites (1)

Research & Development Department

Carlisle, Cumbria, CA1 3SX, United Kingdom

Location

MeSH Terms

Conditions

Foot Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Leon Jonker, PhD

  Cumbria Partnership NHS Trust, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: March 20, 2019
• Study Start: July 27, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)