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Clinical Trials/ISRCTN11300898
ISRCTN11300898
Completed
未知

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

orth Cumbria Integrated Care NHS Foundation Trust0 sites131 target enrollmentJuly 17, 2023
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ConditionsChronic ulcer wounds of the legs and feetSkin and Connective Tissue Diseases

Overview

Phase
未知
Intervention
Not specified
Conditions
Chronic ulcer wounds of the legs and feet
Sponsor
orth Cumbria Integrated Care NHS Foundation Trust
Enrollment
131
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
who.int
Start Date
July 17, 2023
End Date
May 30, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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