Pressure UlcerNCT03146845
Evaluation Of An Advanced Borderless Dressing
A study testing ALLEVYN Life Non-Bordered in people with Pressure Ulcer and Leg Ulcer, run by Smith & Nephew, Inc. at 6 sites in United States.
Trial summary
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
- What is being tested?
- ALLEVYN Life Non-Bordered
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jun 2017to 18 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must provide informed consent to participate in the study.
- The subject must be eighteen (18) years of age or older.
- The subject must be willing and able to make all required study visits.
- The subject must be able to follow instructions and be deemed capable of completing the CWIS questionnaire.
- The subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria:
- The ulcer is classified as either:
Show all 13Show fewer
- a pressure ulcer
- a non-ischemic diabetic foot ulcer
- a leg ulcer (arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy)
- The ulcer is, in the opinion of the Investigator, moderate to highly exuding.
- The ulcer would, in the opinion of the Investigator, benefit from a protective dressing.
- The ulcer is not infected based on clinical signs/symptoms.
- A subject with a DFU must have an ankle-brachial index (ABI) of 0.7 or greater, as measured within 30 days of the Screening Visit.
Who cannot join
- Contraindications or hypersensitivity to the use of the ALLEVYN LIFE Non-Bordered, comparator, ancillary products, or their components.
- Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
- The subject's reference ulcer is being treated with a topical antimicrobial dressing.
- Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
- Subjects who have participated previously in this clinical trial.
- Subjects with a history of poor compliance with medical treatment.
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
JPS Health Network
Fort Worth, Texas, 76104
Center for Clinical Research
Martinez, California, 94553
Titan Clinical Solutions
Phoenix, Arizona, 85013
Grace Research Ltd.
Shreveport, Louisiana, 71105
Wound Care Plus, LLC
Summit, Missouri, 64086
UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: A Pilot Randomized Controlled Trial to Evaluate an Advanced Borderless Dressing (ALLEVYN LIFE Non-Bordered) in the Treatment of Chronic Ulcers
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
Read the detailed description
The study is a pilot RCT, which will generate the first comparative clinical, economic, and safety data for use of ALNB in subjects. A small sample of subjects with a range of chronic, moderate to highly exuding ulcer types (LU [arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy], PU, and non-ischemic DFU) will be enrolled and followed for 12 weeks to study the impact on health-related quality of life, ulcer progression and healthcare resource utilization.
- Conditions
- Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
- Being tested
- ALLEVYN Life Non-Bordered, Standard Care
- Keywords
- Diabetic Foot Ulcer, Pressure Ulcer, Leg Ulcer
- Medical subject headings
- Pressure Ulcer, Leg Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLEVYN Life Non-BorderedDevice
Foam Dressing
Standard CareDevice
Foam Dressing
| Study group | Role | What they receive |
|---|---|---|
| ALLEVYN Life Non-Bordered | Experimental | Foam Dressing Receives: Device: ALLEVYN Life Non-Bordered |
| Standard care | Other | Standard care dressing Receives: Device: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period.
The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern.
The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used:
CWIS-PSDL = (Sum of PSDL item scores-N_PSDL)/(N_PSDL "x" 4) ×100, where NPSDL = count of 24 questions completed (experience and stress)
PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale [1-5]) with higher scores indicating a better outcome.
Measured: Baseline through 6 weeks
Secondary outcomes (21)
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
Assessment of the change over time for the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Score at 3 and 12 weeks; CWIS-Well-Being (WB), CWIS-Social Life (SL), CWIS-Global Quality of Life (GQ), CWIS-Quality of Life Scales (SQ) at 3, 6, and 12 weeks.
PSDL, SL, and WB sub-scores are based on 24 (score range 24-120), 14 (score range 14-70), and 7 (score range 7-35) questions, respectively; (each graded on a 5-point Likert scale [1-5])
Higher scores on all CWIS metrics indicate a better outcome.
PSDL score = (sum of PSDL item scores - 24)/96 x 100 = calculated score of 0 to 100; e.g., 95-24/96 x 100 = 74 (of a possible 100)
WB Score = (sum of WB item scores - 7)/28 x 100 = calculated score of 0 to 100
SL Score = (sum of SL item scores - 14)/56 x 100 = calculated score of 0 to 100
GQ Score = "How good is your quality of life" = score range 0 to 10
SQ Score = "How satisfied are you with your overall quality of life" = score range 0 to 10
Measured: PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks
Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) for an overall wound score at each time point.
The mBWAT score combined the sub-scores of mBWAT - a tool that has been in widespread use since the early 1990s.
mBWAT scoring: There are 13 categories of assessment with item-level score range of 1 to 5 on a modified Likert scale. Each item is scored for the wound characteristic it describes where 1 indicates least severe and 5 indicates most severe with higher scores indicating a more severe wound status. Scores taken over a period of time can be used to track the progression of the wound healing process. Possible score range from 13 to 65 for the total score.
The 13 sub-categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the type of wound exudate exhibited at each time point.
The tool defines the types of exudate as follows:
Bloody = thin, bright red
Serosanguinous = thin, watery, pale red to pink
Serous = thin, watery, clear
Purulent = thin or thick, opaque tan to yellow
Foul purulent = thick, opaque yellow to green with offensive odor
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of wound exudate demonstrated at each time point.
The tool gives the following category descriptions for amount of exudate:
None = wound tissues dry
Scant = wound tissues moist; no measurable exudate
Small = wound tissues wet; moisture evenly distributed in wound; drainage involves </=25% dressing
Moderate = wound tissues saturated; drainage may or may not be evenly distributed in wound; drainage involves >25% to </=75% dressing
Large = wound tissues bathed in fluid; drainage freely expressed; may or may not be evenly distributed in wound; drainage involves >75% dressing
The tool advises to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to determine percentage of dressing involved with exudate.
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the extent (measurement) of wound undermining at each time point.
The tool guidance is as follows:
Assess by inserting a cotton-tipped applicator under the wound edge;
Advance it as far as it will go without using undue force;
Raise the tip of the applicator so it may be seen or felt on the surface of the skin;
Mark the surface with a pen;
Measure the distance from the mark on the skin to the edge of the wound;
Continue process around the wound;
Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved.
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for type (appearance) of necrotic tissue at each time point.
The tool defines the categories of necrotic tissue type as follows:
White/gray non-viable tissue = may appear prior to wound opening; skin surface is white or gray
Non-adherent, yellow slough = thin, mucinous substance; scattered throughout wound bed; easily separated from wound tissue
Loosely adherent, yellow slough = thick, stringy, clumps of debris; attached to wound tissue
Adherent, soft, black eschar = soggy tissue; strongly attached to tissue in center or base of wound
Firmly adherent, hard/black eschar = firm, crusty tissue; strongly attached to wound base and edges (like a hard scab)
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of necrotic tissue observed during dressing change at each time point.
The tool guidance is to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to help determine percent of wound involved.
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance of skin color changes surrounding the reference wound at each time point.
The tool guidance is to assess tissues within 4 cm of wound edge. Dark-skinned persons show the colors "bright red" and "dark red" as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the new skin is pink and may never darken.
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance and percentage of granulation tissue in the reference wound at each time point.
Granulation tissue is the growth of small blood vessels and connective tissue to fill in full-thickness wounds. Tissue is healthy when bright, beefy red, shiny, and granular with a velvety appearance. Poor vascular supply appears as pale-pink or blanched to dull, dusky red color.
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the percentage of reference wound demonstrating epithelialization at each time point.
Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial-thickness wounds, it can occur throughout the wound bed as well as from the wound edges. In full-thickness wounds, it occurs from the edges only.
Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound.
The mBWAT 13 categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization.
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Evaluation of the number of participants demonstrating peri-wound changes in appearance as determined visually by the Investigator; categorized as normal, erythematous, edematous, eczematous, excoriated, macerated, or indurated at each time point.
Measured: Baseline, Weeks 3, 6, and 12
Ulcer Progression Assessed by Change From Baseline in Wound Area
The change from Baseline of the wound area was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound area measurements.
Measured: Baseline, Weeks 3, 6 and 12
Ulcer Progression Assessed by Change From Baseline in Wound Volume
The change from Baseline of the wound volume was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound volume measurements.
Measured: Baseline, Weeks 3, 6, and 12
Ulcer Progression Assessed by Change From Baseline in Wound Depth
The change from Baseline in the wound depth was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound depth measurements.
Measured: Baseline, Weeks 3, 6, and 12
Number of Participants With Reference Wound Healed
Assessment of the wound healed status (100% re-epithelialized, no drainage, no need for dressing) was analyzed at each visit to determine the healing status of the ulcer. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data.
Measured: Weeks 3, 6 and 12
Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used
Analysis of the healthcare resources used related to the reference ulcer included:
Number of primary and secondary dressings including use of compression therapy.
Measured: Baseline through 12 weeks
Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change
Analysis of the healthcare resources used related to the reference ulcer included:
Type of primary and secondary dressings including compression therapy used during each dressing change over the 12-week treatment period based on the size of the ulcer.
Measured: Baseline through 12 weeks
Healthcare Resource Use - Number and Type of Compression Dressings Used
Not all enrolled participants required the use of compression dressings. Of those participants who did require a compression dressing, an analysis of the healthcare resources used included the number and type of primary and secondary dressings used in relation to the reference ulcer.
Measured: Baseline through 12 weeks
Healthcare Resource Use - Number of Participants Requiring Hospital Admission
Analysis of the healthcare resources used for participants who required a hospital admission related to the reference ulcer.
Measured: Baseline through 12 weeks
Healthcare Resource Use - Number of Days Participants Required In-Hospital Care
Analysis of the healthcare resources used related to the reference ulcer included: Time in hospital (number of days spent as an inpatient due to reference ulcer).
Measured: Baseline through 12 weeks
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Analysis of the healthcare resources used related to the reference ulcer included:
Interventions/procedures related to the reference ulcer (number and type) including debridement of the ulcer.
Measured: Baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start15 Jun 2017
- Primary completion12 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachael Winter, Study director, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146845
- Sponsor's protocol ID
- CT1603ALF
- Status last verified
- Nov 2018
- First submitted
- 8 May 2017
- Last updated
- 10 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial to Evaluate an Advanced Borderless Dressing (ALLEVYN LIFE Non-Bordered) in the Treatment of Chronic Ulcers
- ClinicalTrials.gov ID
- NCT03146845
- Acronym / sponsor ID
- CT1603ALF
- Conditions
- Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, Pressure Ulcer, Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Posted 10 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
Detailed description
The study is a pilot RCT, which will generate the first comparative clinical, economic, and safety data for use of ALNB in subjects. A small sample of subjects with a range of chronic, moderate to highly exuding ulcer types (LU [arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy], PU, and non-ischemic DFU) will be enrolled and followed for 12 weeks to study the impact on health-related quality of life, ulcer progression and healthcare resource utilization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLEVYN Life Non-Bordered | Experimental | Device: ALLEVYN Life Non-BorderedFoam Dressing |
| Standard care | Other | Device: Standard CareStandard care dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The subject must provide informed consent to participate in the study.
- The subject must be eighteen (18) years of age or older.
- The subject must be willing and able to make all required study visits.
- The subject must be able to follow instructions and be deemed capable of completing the CWIS questionnaire.
- The subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria:
Key exclusion criteria (7 listed)
- Contraindications or hypersensitivity to the use of the ALLEVYN LIFE Non-Bordered, comparator, ancillary products, or their components.
- Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
- The subject's reference ulcer is being treated with a topical antimicrobial dressing.
- Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
- Subjects who have participated previously in this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLEVYN Life Non-BorderedFoam Dressing | Device | ALLEVYN Life Non-Bordered |
| Standard CareFoam Dressing | Device | Standard care |
Primary outcome
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
Time frame: Baseline through 6 weeks
The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N_PSDL)/(N_PSDL "x" 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale [1-5]) with higher scores indicating a better outcome.
21 secondary outcomes
Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks
Time frame: PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks
Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
Time frame: Baseline, Weeks 3, 6, and 12
Ulcer Progression Assessed by Change From Baseline in Wound Area
Time frame: Baseline, Weeks 3, 6 and 12
Ulcer Progression Assessed by Change From Baseline in Wound Volume
Time frame: Baseline, Weeks 3, 6, and 12
Ulcer Progression Assessed by Change From Baseline in Wound Depth
Time frame: Baseline, Weeks 3, 6, and 12
Number of Participants With Reference Wound Healed
Time frame: Weeks 3, 6 and 12
Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used
Time frame: Baseline through 12 weeks
Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change
Time frame: Baseline through 12 weeks
Healthcare Resource Use - Number and Type of Compression Dressings Used
Time frame: Baseline through 12 weeks
Healthcare Resource Use - Number of Participants Requiring Hospital Admission
Time frame: Baseline through 12 weeks
Healthcare Resource Use - Number of Days Participants Required In-Hospital Care
Time frame: Baseline through 12 weeks
Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
Time frame: Baseline through 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael Winter study director
Smith & Nephew, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALLEVYN Life Non-Bordered in people with Pressure Ulcer and Leg Ulcer, run by Smith & Nephew, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit (time frame: Baseline through 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.