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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05632250
Other study ID # WC-22-427
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2023
Est. completion date March 13, 2024

Study information

Verified date April 2024
Source ConvaTec Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of Chronic leg ulcers (including diabetic foot ulcers) and Pressure Injuries (Grade II and above)


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date March 13, 2024
Est. primary completion date March 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients aged 18 years and over - 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 allergies to any of the materials used in the dressing - 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

Study Design


Intervention

Device:
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.

Locations

Country Name City State
United States Foot and Ankle Specialists of the Mid-Atlantic Hagerstown Maryland
United States Hope Vascularity & Podiatry, PLLC Houston Texas
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

Sponsors (1)

Lead Sponsor Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds. This will be measured by:
Lack of strike through
Loss of edge seal/adherence,
Dressing leakage/seepage
Dislodgement
Need for dressing change
12 weeks
Secondary To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use Performance will be measured by documenting the progress of the wound through a weekly standard wound assessment where progression with be measured by changes to the wound healing status from deteriorating to static, static to improvement or improved to healed 12 weeks
Secondary To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use As part of the study schedule Health Care Professionals to complete a questionnaire at the end of study to assess:
Ease of use
Ease of removal ( Atraumatic)
Wear time (meets recommended guidelines in IFU)
12 weeks
Secondary To measure the performance of ConvaFoam dressings in the management of chronic wounds from a patient perspective when used in accordance with the instructions for use As part of the study schedule patients will be asked to complete a quality of life questionnaire on their first and final visit to measure:
Dressing comfort ( patient satisfied with dressing comfort and able to resume activities of daily living
12 weeks
Secondary To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use Any device related adverse events such as wound complications, maceration, blistering, breakdown of peri wound skin edges or changes to skin integrity will be documented and reported as per protocol 12 weeks
Secondary To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use Any device related adverse events such will be documented and reported as per protocol 12 weeks
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