Clinical trial NCT05892341: AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Official title: A Clinical Study to Compare the Performance of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® Dressing in the Management of Patients With Venous Leg Ulcers Over a 12-week Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Diabetic Foot
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2023-06-07
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing

Detailed description: Post market, multi-centre, randomised, open label, multi-national, prospective study to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing

Eligibility criteria: Inclusion Criteria:

* Venous insufficiency as defined by CEAP Classification of C6
* One wound amendable to treatment with either AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
* Wounds that have been present for at least 2 months
* Reliable and available for follow-up
* 18 years or older
* Able and willing to provide informed consent
* Able to tolerate compression therapy for Venus Leg Ulcer
* Must be able to be compliant with compression therapy

Exclusion Criteria:

* Known sensitivities or allergies to components of the AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
* Continued use of petroleum gel/ creams/ oil-based products
* Active treatment for cancer or completed within the last 3 months
* Documented severe malnutrition
* Malignant wounds
* Systemic infection actively treated with antibiotics

Primary outcomes:
measure: Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on wound management
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Wound healing assessment
timeFrame: Up to 4 weeks
measure: Wound progress assessment
timeFrame: Up to 4 weeks
measure: Wound change assessment
timeFrame: Up to 12 weeks
measure: Safety assesment
timeFrame: Up to 12 weeks
Other outcomes:
measure: Pain assessment
timeFrame: Up to 12 weeks
measure: Quality of Life assesment
timeFrame: Up to 12 weeks
Locations:
city: Barranquilla
country: Colombia
facility: Convatec Colombia Clinic
city: Bogotá
country: Colombia
facility: Convatec Colombia Clinic
city: Bucaramanga
country: Colombia
facility: Convatec Colombia Clinic
city: Cali
country: Colombia
facility: Convatec Colombia Clinic
city: Cartagena
country: Colombia
facility: Convatec Colombia Clinic
city: Medellín
country: Colombia
facility: Convatec Colombia Clinic
city: Augsburg
country: Germany
facility: Germany
city: Berlin
country: Germany
facility: Germany
city: Bochum
country: Germany
facility: Germany
city: Düsseldorf
country: Germany
facility: Germany
city: Holzkirchen
country: Germany
facility: Germany
city: Ingolstadt
country: Germany
facility: Germany
city: München
country: Germany
facility: Germany Clinic II
city: München
country: Germany
facility: Germany Clinic I
city: Nürnberg
country: Germany
facility: Germany
city: Ratzeburg
country: Germany
facility: Germany
city: Rosenheim
country: Germany
facility: Germany
city: Derby
country: United Kingdom
facility: VCTC UK
Study officials:
affiliation: Convatec Colombia Clinic
name: Catarina Saavedra, MD
role: PRINCIPAL_INVESTIGATOR
References: