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.
NCT ID: NCT05632250
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2023-04-10
2024-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ConvaFoam dressings
All participants wounds will be assessed and allocated a dressing based upon the investigator's clinical judgement. They will receive either ConvaFoam Border, Silicone or Non-Adhesive for up to 12 weeks as part of their standard of care
ConvaFoam
ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. Patient's wounds will be assessed and a dressing from the above will be applied as part of their normal standard of care. The wounds will be assessed on a weekly basis for up to 12 weeks.
Interventions
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ConvaFoam
ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. Patient's wounds will be assessed and a dressing from the above will be applied as part of their normal standard of care. The wounds will be assessed on a weekly basis for up to 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients able and willing to provide informed consent
* Patients with wounds with a duration of no less than 2 months and no more than 12 months
* Patients must be willing to complete the QoL (quality of life) questionnaires via a valid email address
* Patients 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 greater
* Patients must be willing to attend visits as per schedule in protocol
Exclusion Criteria
* Patients with known malignant wounds
* Patients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
* Patients, who in the opinion of the Investigator, are considered as unsuitable for any other reason
* Patients 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
18 Years
ALL
No
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kerem Ozere, MD
Role: STUDY_DIRECTOR
Medical Director
Locations
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Foot and Ankle Specialists of the Mid-Atlantic
Hagerstown, Maryland, United States
NYU Langone Health
Mineola, New York, United States
Foot and Ankle Specialsts of the Mid-Atlantic
Raleigh, North Carolina, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Hope Vascularity & Podiatry, PLLC
Houston, Texas, United States
Countries
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Other Identifiers
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WC-22-427
Identifier Type: -
Identifier Source: org_study_id
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