Back to resultsA 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. (MORGEN)
Primary Purpose
Chronic Ulcer of Leg or Foot, Pressure Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ConvaFoam
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Ulcer of Leg or Foot
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ConvaFoam dressings
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05632250
Brief Title
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.
Acronym
MORGEN
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 31, 2023 (Anticipated)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
August 9, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConvaTec Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ulcer of Leg or Foot, Pressure Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Post Market Clinical Follow Up Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ConvaFoam dressings
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
ConvaFoam
Other Intervention Name(s)
ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non Adhesive
Intervention Description
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.
Primary Outcome Measure Information:
Title
To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.
Description
This will be measured by:
Lack of strike through
Loss of edge seal/adherence,
Dressing leakage/seepage
Dislodgement
Need for dressing change
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use
Description
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
Time Frame
12 weeks
Title
To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use
Description
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)
Time Frame
12 weeks
Title
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
Description
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
Time Frame
12 weeks
Title
To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use
Description
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
Time Frame
12 weeks
Title
To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use
Description
Any device related adverse events such will be documented and reported as per protocol
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisha Oropallo, MD
Phone
001 516 233-3780
Email
aoropallo@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Kaplan
Phone
001 516 233-3780
Email
skaplan2@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerem Ozere, MD
Organizational Affiliation
Medical Director
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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