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NCT05632250
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
Conditions: Chronic Ulcer of Leg or Foot, Pressure Injury
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: ConvaTec Inc.
Summary
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
Eligibility Criteria
Inclusion Criteria:Patients aged 18 years and overPatients able and willing to provide informed consentPatients with wounds with a duration of no less than 2 months and no more than 12 monthsPatients must be willing to complete the QoL (quality of life) questionnaires via a valid email addressPatients with at least one, but no more than two of the same wound indications which would require dressing according to the stage of the wound:Chronic ulcers (Venous, arterial, mixed aetiology or diabetic foot ulcers)Pressure Injury Stage II or greaterPatients must be willing to attend visits as per schedule in protocolExclusion Criteria:Patients with known allergies to any of the materials used in the dressingPatients with known malignant woundsPatients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutionsPatients, who in the opinion of the Investigator, are considered as unsuitable for any other reasonPatients with chronic conditions such as autoimmune disorders in an acute flare phase, which in the opinion of the investigator would directly impact wound healing, use of immunosuppressant medications may be allowed if they have been on a stable dose and regimen over the past three months
Source: ClinicalTrials.gov (NCT05632250). StuddyBuddy aggregates publicly available trial information.