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. (MORGEN)

Convatec

Status: Completed

Conditions: Chronic Ulcer of Leg or Foot; Pressure Injury

Treatments: Device: ConvaFoam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05632250

WC-22-427

Details and patient eligibility

About

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.

Full 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)

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

ConvaFoam dressings

Other group

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

Treatment:

Device: ConvaFoam