Diabetic Foot Ulcer, Venous Leg Ulcer
Conditions
Brief summary
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border). The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
Detailed description
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) The properties of a wound dressing can have a significant impact on wound healing and on the risk of developing infections. The ideal wound dressing should have good contact with the wound and be effective in absorbing and holding fluids. Biatain® Silicone uses 3DFit technology, which may support better contact with the wound, help to absorb fluid more effectively and reduce the risk of leakage. These properties may support faster wound healing and reduce complications. This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border). All products used in this study are CE-marked medical devices which are already available in the UK. The main objective is to compare the reduction in wound area over four weeks between the two treatment groups. The study will also look at other aspects of wound healing and compare the costs of the dressings and the participants' quality of life during the study period. In a subgroup of participants, ultrasound will be used to assess the contact between the dressings and the wound. The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. Participants will be inpatients or outpatients recruited through 12-18 Tissue Viability Units and hospitals across the UK. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
Interventions
DEVICEBiatain® Silicone
Wound care dressing
DEVICEMepilex Border with Aquacel Extra Hydrofiber
Wound care dressing
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The clinical investigation is a two-arms, open-labelled, stratified, randomized, controlled, multicentre investigation comparing the clinical performance of Biatain® Silicone with standard of care in chronic wounds with wound depth down to 20 mm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has given written consent to participate by signing the Informed Consent Signature Form * Is at least 18 years of age and has full legal capacity * Has a venous leg ulcer (VLU) (C6 of the CEAP classification(1)) or a non-infected diabetic foot ulcer (DFU) with a duration longer than 8 weeks but no longer than 24 months * Has a wound with depth1 down to 20 mm * Has a maximum wound depth1 relative to wound diameter * Has a wound with exudate levels requiring a filler and a standard secondary dressing * Has acceptance of compression therapy in case of a VLU or off-loading in case of a DFU, according to local standards * For subjects with diabetes, has HbA1c ≤ 10% or ≤ 86 mmol/mol, measured within the last 3 months prior to inclusion
Exclusion criteria
* Wound is infected. For DFUs, has infection severity mild-severe according to the IWGDF/IDSA guideline For VLUs, has 2 or more clinical signs of infection as defined in protocol, based on clinical judgement by investigator/tissue viability nurse * Wounds is with exposed tendons, is with bones or has fistulas * Wound is with cavity, or is undermined or tunnelling * Subject is receiving chemotherapy * Subject has ankle-brachial pressure index (ABPI) below 0.8 measured within one month prior to inclusion * Wound is larger than 10 x10 cm * Currently enrolled in another wound care de-vice investigation unless co-enrolment has been agreed with the sponsor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Wound Area Reduction (WAR) During Four Weeks | Baseline and four weeks | Photos of the wounds were collected at every site visit. A ruler or marker was used for calibration of linear dimensions at the image. Wound size reduction between visit 5 and at baseline was calculated. The mean WAR for each treatment group was calculated. As wounds would become smaller over time, the baseline wound size minus the wound size at visit 5 would be a positive value. If the value is negative this means the wound size has grown in size. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products | Baseline to 4 weeks | Total cost, £, was calculated as the number of products used multiplied by the unit price of the product. The price was extracted from the Drug Tariff on the date of Last Patient Out. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepilex Border With Aquacel Extra Hydrofiber Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing
Mepilex Border with Aquacel Extra Hydrofiber: Wound care dressing | 51 |
| Biatain® Silicone The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler.
Biatain® Silicone: Wound care dressing | 51 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | one screening failure | 0 | 2 |
Baseline characteristics
| Characteristic | Biatain® Silicone | Total | Mepilex Border With Aquacel Extra Hydrofiber |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 12 | 71.6 years STANDARD_DEVIATION 12.1 | 73.5 years STANDARD_DEVIATION 12 |
| body mass index | 30.4 kg/m^2 STANDARD_DEVIATION 7.8 | 30.4 kg/m^2 STANDARD_DEVIATION 8.7 | 30.4 kg/m^2 STANDARD_DEVIATION 9.6 |
| Comorbidities Cardiopulmonary conditions | 19 Participants | 32 Participants | 13 Participants |
| Comorbidities Diabetes | 16 Participants | 32 Participants | 16 Participants |
| Comorbidities Immune deficiencies | 2 Participants | 5 Participants | 3 Participants |
| Comorbidities Other | 12 Participants | 26 Participants | 14 Participants |
| Comorbidities Peripheral arterial disease | 5 Participants | 13 Participants | 8 Participants |
| Comorbidities Venous insufficiency | 41 Participants | 84 Participants | 43 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 21 Participants | 44 Participants | 23 Participants |
| Sex: Female, Male Male | 30 Participants | 58 Participants | 28 Participants |
| Wound age (month) | 5.1 months STANDARD_DEVIATION 4.4 | 5.4 months STANDARD_DEVIATION 4.6 | 5.7 months STANDARD_DEVIATION 4.8 |
| Wound area (subtracted islands) (cm2) | 6.1 cm2 STANDARD_DEVIATION 8.8 | 5.8 cm2 STANDARD_DEVIATION 7.5 | 5.6 cm2 STANDARD_DEVIATION 6.1 |
| Wound depth (mm) | 2.3 mm STANDARD_DEVIATION 2 | 2.5 mm STANDARD_DEVIATION 2.2 | 2.7 mm STANDARD_DEVIATION 2.3 |
| Wound type: Venous leg ulcer; diabetic foot ulcer Diabetic foot ulcer | 12 Participants | 23 Participants | 11 Participants |
| Wound type: Venous leg ulcer; diabetic foot ulcer Venous leg ulcer | 39 Participants | 79 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 1 / 51 |
| other Total, other adverse events | 6 / 51 | 4 / 50 |
| serious Total, serious adverse events | 1 / 51 | 1 / 50 |
Outcome results
Primary
Percentage Wound Area Reduction (WAR) During Four Weeks
Photos of the wounds were collected at every site visit. A ruler or marker was used for calibration of linear dimensions at the image. Wound size reduction between visit 5 and at baseline was calculated. The mean WAR for each treatment group was calculated. As wounds would become smaller over time, the baseline wound size minus the wound size at visit 5 would be a positive value. If the value is negative this means the wound size has grown in size.
Time frame: Baseline and four weeks
Population: The intention to treat population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mepilex Border With Aquacel Extra Hydrofiber | Percentage Wound Area Reduction (WAR) During Four Weeks | 43 Percentage of wound area reduction |
| Biatain® Silicone | Percentage Wound Area Reduction (WAR) During Four Weeks | 54.3 Percentage of wound area reduction |
Secondary
Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products
Total cost, £, was calculated as the number of products used multiplied by the unit price of the product. The price was extracted from the Drug Tariff on the date of Last Patient Out.
Time frame: Baseline to 4 weeks
Population: Intention to treat population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mepilex Border With Aquacel Extra Hydrofiber | Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products | 21.4 mean £ |
| Biatain® Silicone | Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products | 14.3 mean £ |