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.
Completed · Not applicable
Conditions studied: Chronic Ulcer of Leg or Foot, Pressure Injury
In brief
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.
Key facts
- Study ID
- NCT05632250
- Run by
- ConvaTec Inc.
- People needed
- 95
- Starts
- 2023-04-10
- Expected to finish
- 2024-03-13
- Last updated by the study team
- 2024-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Foot and Ankle Specialists of the Mid-Atlantic — Hagerstown, Maryland, United States
- NYU Langone Health — Mineola, New York, 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
Full record on ClinicalTrials.gov
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