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.

Not Applicable

Completed

Brief 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.

Detailed 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 & 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

Arm && Interventions

Group	Intervention	Description
ConvaFoam dressings	ConvaFoam	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

Primary Outcome Measures

Name	Time	Method
To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.	12 weeks	This will be measured by: Lack of strike through Loss of edge seal/adherence, Dressing leakage/seepage Dislodgement Need for dressing change

Secondary Outcome Measures

Name	Time	Method
To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use	12 weeks	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)
To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use	12 weeks	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
To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use	12 weeks	Any device related adverse events such will be documented and reported as per protocol
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	12 weeks	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

Locations (5): NYU Langone Health
🇺🇸
Mineola, New York, United States
Foot and Ankle Specialists of the Mid-Atlantic
🇺🇸
Hagerstown, Maryland, 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