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
| Verified date | March 2024 |
| Source | ConvaTec Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| ConvaTec Inc. | NAMSA |
Colombia, Germany, United Kingdom,
| 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 |
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