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AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
NA trial testing AQUACEL® Ag+ Extra™ in Venous Leg Ulcer in 203 participants. Completed in 14 February 2024.
| Lead sponsor | ConvaTec Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 203 |
| Start date | 5 December 2022 |
| Primary completion | 14 February 2024 |
| Estimated completion | 14 February 2024 |
| Sites | 18 locations across Colombia, United Kingdom, Germany |
ConvaTec Inc.
18 and older, any sex, with Venous Leg Ulcer or Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)
| Group | Value | 95% CI |
|---|---|---|
| AQUACEL® Ag+ Extra™ | 80 | |
| Cutimed® Sorbact® | 60 |
Percent change in study wound area
| Group | Value | 95% CI |
|---|---|---|
| AQUACEL® Ag+ Extra™ | -62.66 | ± 43.54 |
| Cutimed® Sorbact® | -48.31 | ± 49.97 |
Satisfactory clinical progress defined as 40% reduction in study wound area
| Group | Value | 95% CI |
|---|---|---|
| AQUACEL® Ag+ Extra™ | 81 | 69.11 – 85.17 |
| Cutimed® Sorbact® | 70 | 55.81 – 73.82 |
Percent change in target wound area
| Group | Value | 95% CI |
|---|---|---|
| AQUACEL® Ag+ Extra™ | -90.33 | ± 27.09 |
| Cutimed® Sorbact® | -67.22 | ± 55.13 |
Summary of the incidence of adverse events (AEs), device-related adverse events (ADEs) and serious device-related adverse events (SADEs)
| Group | Value | 95% CI |
|---|---|---|
| AQUACEL® Ag+ Extra™ | 11 | |
| Cutimed® Sorbact® | 27 |
| Group | Value | 95% CI |
|---|---|---|
| AQUACEL® Ag+ Extra™ | 3 | |
| Cutimed® Sorbact® | 6 |
| Group | Value | 95% CI |
|---|---|---|
| AQUACEL® Ag+ Extra™ | 1 | |
| Cutimed® Sorbact® | 4 |
| Group | Value | 95% CI |
|---|---|---|
| AQUACEL® Ag+ Extra™ | 0 | |
| Cutimed® Sorbact® | 1 |
Time frame: Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | AQUACEL® Ag+ Extra™ | Cutimed® Sorbact® |
|---|---|---|---|
| Ischaemic heart disease | Cardiac disorders | — | — |
| Gastrointestinal bleeding | Gastrointestinal disorders | — | — |
| Death | General disorders | — | — |
| Allergic reaction to drug | Immune system disorders | — | — |
| Cellulitis on left lower leg | Infections and infestations | — | — |
| Chest infection | Infections and infestations | — | — |
| UTI | Infections and infestations | — | — |
| Unspecified local infection of skin and subcutaneous tissue | Infections and infestations | — | — |
| Reaction | System | AQUACEL® Ag+ Extra™ | Cutimed® Sorbact® |
|---|---|---|---|
| Wound infection | Infections and infestations | — | — |
| Infection | Infections and infestations | — | — |
| Wound pain | Injury, poisoning and procedural complications | — | — |
| UTI | Infections and infestations | — | — |
| Ulcer bleeding | General disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Overgranulation | Skin and subcutaneous tissue disorders | — | — |
| Unilateral leg swelling | General disorders | — | — |
| Thrush | Infections and infestations | — | — |
| Thumb osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Leg ulcer (not study ulcer) | Skin and subcutaneous tissue disorders | — | — |
| Open wound | Injury, poisoning and procedural complications | — | — |
| Itching all over | Skin and subcutaneous tissue disorders | — | — |
| Ulcer | General disorders | — | — |
| Pressure ulcer | Skin and subcutaneous tissue disorders | — | — |
| Cellulitis of abdominal wall | Infections and infestations | — | — |
| Hypercholesterolemia | Metabolism and nutrition disorders | — | — |
| Venous ulcer recurrent | Skin and subcutaneous tissue disorders | — | — |
| Infected skin ulcer | Infections and infestations | — | — |
| Varicose veins of lower extremities with ulcer | Vascular disorders | — | — |
| Wound | Infections and infestations | — | — |
Most-reported serious reactions: Ischaemic heart disease, Gastrointestinal bleeding, Death, Allergic reaction to drug, Cellulitis on left lower leg, Chest infection, UTI, Unspecified local infection of skin and subcutaneous tissue.
Data from ClinicalTrials.gov NCT05892341 adverse events section.
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
2 peer-reviewed publications reference this trial (live from Europe PMC):
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