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Completed

NCT Number: 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.

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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Key information

Conditions

Chronic Ulcer of Leg or Foot Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foot and Ankle Specialists of the Mid-Atlantic, Hagerstown, Maryland, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ConvaFoam

Device

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 names: ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non Adhesive

Primary outcomes

  1. To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.

    Time frame: 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 outcomes

  1. To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use

    Time frame: 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

  2. To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use

    Time frame: 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)

  3. 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

    Time frame: 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

  4. To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use

    Time frame: 12 weeks

    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

  5. To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use

    Time frame: 12 weeks

    Any device related adverse events such will be documented and reported as per protocol

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study 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.

Acronym: MORGEN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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