Back to resultsAQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Primary Purpose
Venous Leg Ulcer, Diabetic Foot
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AQUACEL® Ag+ Extra™
Cutimed® Sorbact®
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
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
Sites / Locations
- Convatec Colombia ClinicRecruiting
- Convatec Colombia ClinicRecruiting
- Convatec Colombia ClinicRecruiting
- Convatec Colombia ClinicRecruiting
- Convatec Colombia ClinicRecruiting
- Convatec Colombia ClinicRecruiting
- GermanyRecruiting
- GermanyRecruiting
- GermanyRecruiting
- GermanyRecruiting
- GermanyRecruiting
- GermanyRecruiting
- Germany Clinic IIRecruiting
- Germany Clinic IRecruiting
- GermanyRecruiting
- GermanyRecruiting
- GermanyRecruiting
- Germany
- Poland
- UKRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AQUACEL® Ag+ Extra™
Cutimed® Sorbact®
Arm Description
AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing
Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Wound healing assessment
Percent change in study wound area
Wound progress assessment
Satisfactory clinical progress defined as 40% reduction in study wound area
Wound change assessment
Percent change in target wound area
Safety assesment
Summary of the incidence of adverse events (AEs), device-related AEs and serious device-related AEs
Full Information
NCT ID
NCT05892341
First Posted
May 10, 2023
Last Updated
October 24, 2023
Sponsor
ConvaTec Inc.
Collaborators
NAMSA
1. Study Identification
Unique Protocol Identification Number
NCT05892341
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
February 16, 2024 (Anticipated)
Study Completion Date
February 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConvaTec Inc.
Collaborators
NAMSA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Diabetic Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AQUACEL® Ag+ Extra™
Arm Type
Active Comparator
Arm Description
AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing
Arm Title
Cutimed® Sorbact®
Arm Type
Active Comparator
Arm Description
Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing
Intervention Type
Device
Intervention Name(s)
AQUACEL® Ag+ Extra™
Intervention Description
Wound treatment with AQUACEL® Ag+ Extra™ dressing
Intervention Type
Device
Intervention Name(s)
Cutimed® Sorbact®
Intervention Description
Wound treatment with Cutimed® Sorbact® dressing
Primary Outcome Measure Information:
Title
Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on wound management
Description
Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Wound healing assessment
Description
Percent change in study wound area
Time Frame
Up to 4 weeks
Title
Wound progress assessment
Description
Satisfactory clinical progress defined as 40% reduction in study wound area
Time Frame
Up to 4 weeks
Title
Wound change assessment
Description
Percent change in target wound area
Time Frame
Up to 12 weeks
Title
Safety assesment
Description
Summary of the incidence of adverse events (AEs), device-related AEs and serious device-related AEs
Time Frame
Up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Pain assessment
Description
Numeric Rating Scale from 0 to 10
Time Frame
Up to 12 weeks
Title
Quality of Life assesment
Description
Wound-QoL-14 global score
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catarina Saavedra, MD
Phone
3173637942
Email
info@clinicasesteticas.com.co
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Stuecker, MD
Email
info@klinikum-bochum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catarina Saavedra, MD
Organizational Affiliation
Convatec Colombia Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Convatec Colombia Clinic
City
Barranquilla
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Convatec Colombia Clinic
City
Bogotá
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Convatec Colombia Clinic
City
Bucaramanga
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Convatec Colombia Clinic
City
Cali
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Convatec Colombia Clinic
City
Cartagena
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Convatec Colombia Clinic
City
Medellín
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Germany
City
Augsburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Bochum
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Holzkirchen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Ingolstadt
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany Clinic II
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany Clinic I
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Nürnberg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Ratzeburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Rosenheim
Country
Germany
Individual Site Status
Recruiting
Facility Name
Germany
City
Wernigerode
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Poland
City
Lublin
Country
Poland
Individual Site Status
Withdrawn
Facility Name
UK
City
Derby
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
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