AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period

Diabetic Foot Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892341
• Other study ID #: WC-22-435
• Status: Completed
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: February 14, 2024

Study information

• Verified date: March 2024
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: February 14, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• AQUACEL® Ag+ Extra™
Wound treatment with AQUACEL® Ag+ Extra™ dressing
• Cutimed® Sorbact®
Wound treatment with Cutimed® Sorbact® dressing

Locations

Country	Name	City	State
Colombia	Convatec Colombia Clinic	Barranquilla
Colombia	Convatec Colombia Clinic	Bogotá
Colombia	Convatec Colombia Clinic	Bucaramanga
Colombia	Convatec Colombia Clinic	Cali
Colombia	Convatec Colombia Clinic	Cartagena
Colombia	Convatec Colombia Clinic	Medellín
Germany	Germany	Augsburg
Germany	Germany	Berlin
Germany	Germany	Bochum
Germany	Germany	Düsseldorf
Germany	Germany	Holzkirchen
Germany	Germany	Ingolstadt
Germany	Germany Clinic I	München
Germany	Germany Clinic II	München
Germany	Germany	Nürnberg
Germany	Germany	Ratzeburg
Germany	Germany	Rosenheim
United Kingdom	VCTC UK	Derby

Sponsors (2)

Lead Sponsor	Collaborator
ConvaTec Inc.	NAMSA

Countries where clinical trial is conducted

Colombia,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain assessment	Numeric Rating Scale from 0 to 10	Up to 12 weeks
Other	Quality of Life assesment	Wound-QoL-14 global score	Up to 12 weeks
Primary	Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on wound management	Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)	Up to 12 weeks
Secondary	Wound healing assessment	Percent change in study wound area	Up to 4 weeks
Secondary	Wound progress assessment	Satisfactory clinical progress defined as 40% reduction in study wound area	Up to 4 weeks
Secondary	Wound change assessment	Percent change in target wound area	Up to 12 weeks
Secondary	Safety assesment	Summary of the incidence of adverse events (AEs), device-related AEs and serious device-related AEs	Up to 12 weeks