Diabetic Foot, Venous Leg Ulcer
Conditions
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
Interventions
DEVICEAQUACEL® Ag+ Extra™
Wound treatment with AQUACEL® Ag+ Extra™ dressing
DEVICECutimed® Sorbact®
Wound treatment with Cutimed® Sorbact® dressing
Sponsors
NAMSA
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management | Up to 12 weeks | Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Assessment | Up to 4 weeks | Percent change in study wound area |
| Wound Progress Assessment | Up to 4 weeks | Satisfactory clinical progress defined as 40% reduction in study wound area |
| Wound Change Assessment | Up to 12 weeks | Percent change in target wound area |
| Safety Assesment | Up to 12 weeks | Summary of the incidence of adverse events (AEs), device-related adverse events (ADEs) and serious device-related adverse events (SADEs) |
Countries
Colombia, Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AQUACEL® Ag+ Extra™ AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing
AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing | 101 |
| Cutimed® Sorbact® Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing
Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing | 102 |
| Total | 203 |
Baseline characteristics
| Characteristic | AQUACEL® Ag+ Extra™ | Cutimed® Sorbact® | Total |
|---|---|---|---|
| Age, Customized < 65 | 38 Participants | 42 Participants | 80 Participants |
| Age, Customized 65-79 | 44 Participants | 41 Participants | 85 Participants |
| Age, Customized 80+ | 19 Participants | 19 Participants | 38 Participants |
| BMI | 31.84 kg/m2 STANDARD_DEVIATION 8.26 | 30.06 kg/m2 STANDARD_DEVIATION 6.12 | 30.95 kg/m2 STANDARD_DEVIATION 7.19 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Colombia | 59 Participants | 59 Participants | 118 Participants |
| Region of Enrollment Germany | 22 Participants | 21 Participants | 43 Participants |
| Region of Enrollment United Kingdom | 20 Participants | 22 Participants | 42 Participants |
| Sex: Female, Male Female | 71 Participants | 56 Participants | 127 Participants |
| Sex: Female, Male Male | 30 Participants | 46 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 1 / 102 |
| other Total, other adverse events | 8 / 101 | 21 / 102 |
| serious Total, serious adverse events | 3 / 101 | 6 / 102 |
Outcome results
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)
Time frame: Up to 12 weeks
Population: Proportion of study wounds with complete wound healing by Week 12
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| AQUACEL® Ag+ Extra™ | Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management | 80 Number of Wounds |
| Cutimed® Sorbact® | Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management | 60 Number of Wounds |
Secondary
Safety Assesment
Summary of the incidence of adverse events (AEs), device-related adverse events (ADEs) and serious device-related adverse events (SADEs)
Time frame: Up to 12 weeks
Population: Proportion of subjects with AEs, SAEs, ADEs and Unanticipated Adverse Device Effects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AQUACEL® Ag+ Extra™ | Safety Assesment | Any AE, subjects | 11 participants |
| AQUACEL® Ag+ Extra™ | Safety Assesment | Any SAE, subjects | 3 participants |
| AQUACEL® Ag+ Extra™ | Safety Assesment | Adverse Device Effects | 1 participants |
| AQUACEL® Ag+ Extra™ | Safety Assesment | Serious Adverse Device Effect | 0 participants |
| Cutimed® Sorbact® | Safety Assesment | Serious Adverse Device Effect | 1 participants |
| Cutimed® Sorbact® | Safety Assesment | Any AE, subjects | 27 participants |
| Cutimed® Sorbact® | Safety Assesment | Adverse Device Effects | 4 participants |
| Cutimed® Sorbact® | Safety Assesment | Any SAE, subjects | 6 participants |
Secondary
Wound Change Assessment
Percent change in target wound area
Time frame: Up to 12 weeks
Population: Percent change in wound size at Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AQUACEL® Ag+ Extra™ | Wound Change Assessment | -90.33 Percent change in wound size | Standard Deviation 27.09 |
| Cutimed® Sorbact® | Wound Change Assessment | -67.22 Percent change in wound size | Standard Deviation 55.13 |
Secondary
Wound Healing Assessment
Percent change in study wound area
Time frame: Up to 4 weeks
Population: Percent change in wound size at Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AQUACEL® Ag+ Extra™ | Wound Healing Assessment | -62.66 Percent change in wound size | Standard Deviation 43.54 |
| Cutimed® Sorbact® | Wound Healing Assessment | -48.31 Percent change in wound size | Standard Deviation 49.97 |
Secondary
Wound Progress Assessment
Satisfactory clinical progress defined as 40% reduction in study wound area
Time frame: Up to 4 weeks
Population: Proportion of study wounds with satisfactory clinical progress defined as 40% reduction in study wound area at 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AQUACEL® Ag+ Extra™ | Wound Progress Assessment | 81 Number of Wounds |
| Cutimed® Sorbact® | Wound Progress Assessment | 70 Number of Wounds |