Clinical trial 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.
Official title: 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 Indicated Chronic Wound Types.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ulcer of Leg or Foot
Pressure Injury
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Post Market Clinical Follow Up Study
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.
timeFrame: 12 weeks
Secondary outcomes:
measure: To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use
timeFrame: 12 weeks
measure: To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use
timeFrame: 12 weeks
measure: To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hagerstown
country: United States
facility: Foot and Ankle Specialists of the Mid-Atlantic
state: Maryland
city: Mineola
country: United States
facility: NYU Langone Health
state: New York
city: Raleigh
country: United States
facility: Foot and Ankle Specialsts of the Mid-Atlantic
state: North Carolina
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Houston
country: United States
facility: Hope Vascularity & Podiatry, PLLC
state: Texas
Study officials:
affiliation: Medical Director
name: Kerem Ozere, MD
role: STUDY_DIRECTOR
References: