Chronic WoundNCT03662997
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
A study testing Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing and Hydrocellular Multi-Layer Foam Dressing in people with Chronic Wound and Venous Leg Ulcer, run by Molnlycke Health Care AB at 5 sites in United States.
Trial summary
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- What is being tested?
- Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing and Hydrocellular Multi-Layer Foam Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Mar 2019to 15 Nov 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
- Signed informed consent.
- Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
- Study subject must be available and able to visit the clinic weekly for the full 4-week period.
Who cannot join
- Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
- Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
- Subject has any evidence of peripheral arterial disease (PAD).
- Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
- Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
- Pregnancy or lactation at time of study participation.
Show all 11Show fewer
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
- Present history of alcohol or drug abuse.
- Known allergy/hypersensitivity to any of the components of the dressing.
- Subject not suitable for the investigation according to the investigator's judgment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Center for Clinical Research, Inc.
Castro Valley, California, 94546
Vascular and Wound Care Center
Newark, New Jersey, 07101
SerenaGroup Research Foundation
Pittsburgh, Pennsylvania, 15222
SerenaGroup
Pittsburgh, Pennsylvania, 15232
Center for Clinical Trials, Inc.
San Francisco, California, 94115
About this study
Official title: A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
Read the detailed description
The study will be conducted in an outpatient setting of an academic clinical center over a total period of four weeks (28 days, -1/+2).
The aim of this RCT is to evaluate and compare three different foam dressings in the local management of chronic wounds (i.e. venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs)) in an outpatient setting. A bordered, five-layer, flexible foam dressing with soft silicone adhesive technology will be evaluated versus a hydropolymer, adhesive foam island dressing and a multi-layered, hydrocellular foam dressing with silicone adhesive, within three focus areas; efficacy and safety of the dressings, participant-centric outcomes and health economic evaluation.
Note: The terms used within the body of this report and results, in both the Primary and Secondary Outcomes, are defined as follows:
Period 1: Weeks 1 and 2 of study follow-up visits. Period 2: Weeks 3 and 4 of study follow-up visits. Week 1: Designates data captured only on visit days 7 and 21. Week 2: Designates data captured only on visit days 14 and 28. During Week 1: Designates data captured on visit days 3, 7, 17 and 21. During Week 2: Designates data captured on visit days 10, 14, 24 and 28. Day 3 of Week 1 from tables: inclusive of data captured on Visit Days 3 and 17. Day 3 of Week 2 from tables: inclusive of data captured on Visit Days 10 and 24.
Day 7 of Week 1 from tables: inclusive of data captured on Visit Days 7 and 21. Day 7 of Week 2 from tables: inclusive of data captured on Visit Days 14 and 28.
- Conditions
- Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- Being tested
- Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing, Hydrocellular Multi-Layer Foam Dressing
- Keywords
- Chronic wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Wound dressing
- Medical subject headings
- Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bordered Five-Layer Foam DressingDevice
Also called Five-layer
Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology
Hydropolymer Foam DressingDevice
Also called Hydropolymer
Hydropolymer, adhesive foam island dressing
Hydrocellular Multi-Layer Foam DressingDevice
Also called Hydrocellular
Multi-layered, hydrocellular foam dressing with silicone adhesive
| Study group | Role | What they receive |
|---|---|---|
| Five-layer vs Hydropolymer | Active comparator | Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks. Receives: Device: Bordered Five-Layer Foam Dressing; Device: Hydropolymer Foam Dressing |
| Hydropolymer vs Five-layer | Active comparator | Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks Receives: Device: Bordered Five-Layer Foam Dressing; Device: Hydropolymer Foam Dressing |
| Five-layer vs Hydrocellular | Active comparator | Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks. Receives: Device: Bordered Five-Layer Foam Dressing; Device: Hydrocellular Multi-Layer Foam Dressing |
| Hydrocellular vs Five-layer | Active comparator | Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks Receives: Device: Bordered Five-Layer Foam Dressing; Device: Hydrocellular Multi-Layer Foam Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Participants With Equal or Better Rate of Dressing Durability
Dressing strike-through determined @ Wk1 Day 3\&7, and Wk3 Day 17\&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset.
Contributing factors to strike-through:
Saturation of dressing pad:
- Inappropriate dressing type
- Inappropriate dressing change freq. (i.e. more frequent changes required)
- Change in wound condition (e.g. increase in exudate amt)
Dislodgement of dressing:
- Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation)
- Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility)
- Patient interference w/ dressing
Dressing design deficiency:
- Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission)
- Insufficient adhesion
- Insufficient conformability (i.e. ability to conform to body contours \& challenging anatomical wound locations)
Measured: 4 weeks
% of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
Intact dressing after 7 days wear time, assessed @ Wk1 Day7 \& Wk3 Day21 only. 1st week of dressing wear (Wks 1 \& 3) is critical for start of wound healing.
Contributing factors to strike-through:
Saturation of dressing pad:
- Inappropriate dressing type
- Inappropriate dressing change freq. (i.e. more frequent changes required)
- Change in wound condition (e.g. increase in exudate amt)
Dislodgement of dressing:
- Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation)
- Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility)
- Patient interference w/ dressing
Dressing design deficiency:
- Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission)
- Insufficient adhesion
- Insufficient conformability (i.e. ability to conform to body contours \& challenging anatomical wound locations)
Measured: Weeks 1 and 3
Secondary outcomes (7)
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
Measured: 4 weeks
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
Measured: 4 weeks
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer
Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.
Measured: 4 weeks
% of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings
Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through.
Measured: 4 weeks
% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation
Wound granulation was measured by visual assessment and photodigital planimetry. Wound granulation were grouped into 6 categories: None, <25%, 25-49%, 50-74%, 75-99%, 100%.
Measured: 4 weeks
% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both)
Non-viable tissue was determined by visual assessment and photodigital planimetry. Non-viable tissues were grouped into 5 categories: None, <25%, 25-49%, 50-74%, 75-100%.
Measured: 4 weeks
Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire
The SF-12 health survey consists of 12 questions that yield an eight-scale profile of functional health and well-being, and 2 component summary measures of physical and mental health. SF-12 scores range from 0 to 100 with lower scores indicate lower levels of health.
SF-12 questionnaire was administered at Screening/Baseline, Day 14, and Day 28 visits, and scored by a 3rd party vendor.
Results are mean differences between five-layer vs the comparator dressing and presented for each of the 8 health domains, and 2 component summary measures.
Negative scores indicate lower SF-12 scores (indicating lower levels of health) for the five-layer treatment group; positive scores indicate higher SF-12 scores for the five-layer group.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start19 Mar 2019
- Primary completion1 Oct 2019
- Study completion15 Nov 2019
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 Chronic WoundStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective RCT using a crossover design to evaluate safety and efficacy. The study will be conducted in an outpatient setting of an academic clinical center. There will be two participant groups: those with VLU and those with DFU. Approximately 50% of the participants will be in the VLU group and 50% of the participants in the DFU group. Treatment sequence will be randomized so that a fair distribution is achieved. Each participant will receive a 2-week treatment with one of the three dressings followed by a 2-week treatment period with a second dressing (i.e. each participant will receive treatment with two different dressings, either the Bordered Five-Layer Foam Dressing and the Hydropolymer Foam Dressing, or the Bordered Five-Layer Foam Dressing and the Hydrocellular Multi-Layer Foam Dressing) using a cross-over (repeated measures) design, with a total of four study arms.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar Alvarez, Principal investigator, Vascular and Wound Care Center, University Hospital, Newark, NJ, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662997
- Sponsor's protocol ID
- MxBFlex02
- Status last verified
- Jan 2020
- First submitted
- 4 May 2018
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study Using Cross-Over Design to Evaluate and Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
- ClinicalTrials.gov ID
- NCT03662997
- Acronym / sponsor ID
- MxBFlex02
- Conditions
- Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- Keywords
- Chronic wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Wound dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
Detailed description
The study will be conducted in an outpatient setting of an academic clinical center over a total period of four weeks (28 days, -1/+2).
The aim of this RCT is to evaluate and compare three different foam dressings in the local management of chronic wounds (i.e. venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs)) in an outpatient setting. A bordered, five-layer, flexible foam dressing with soft silicone adhesive technology will be evaluated versus a hydropolymer, adhesive foam island dressing and a multi-layered, hydrocellular foam dressing with silicone adhesive, within three focus areas; efficacy and safety of the dressings, participant-centric outcomes and health economic evaluation.
Note: The terms used within the body of this report and results, in both the Primary and Secondary Outcomes, are defined as follows:
Period 1: Weeks 1 and 2 of study follow-up visits. Period 2: Weeks 3 and 4 of study follow-up visits. Week 1: Designates data captured only on visit days 7 and 21. Week 2: Designates data captured only on visit days 14 and 28. During Week 1: Designates data captured on visit days 3, 7, 17 and 21. During Week 2: Designates data captured on visit days 10, 14, 24 and 28. Day 3 of Week 1 from tables: inclusive of data captured on Visit Days 3 and 17. Day 3 of Week 2 from tables: inclusive of data captured on Visit Days 10 and 24.
Day 7 of Week 1 from tables: inclusive of data captured on Visit Days 7 and 21. Day 7 of Week 2 from tables: inclusive of data captured on Visit Days 14 and 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a prospective RCT using a crossover design to evaluate safety and efficacy. The study will be conducted in an outpatient setting of an academic clinical center. There will be two participant groups: those with VLU and those with DFU. Approximately 50% of the participants will be in the VLU group and 50% of the participants in the DFU group. Treatment sequence will be randomized so that a fair distribution is achieved. Each participant will receive a 2-week treatment with one of the three dressings followed by a 2-week treatment period with a second dressing (i.e. each participant will receive treatment with two different dressings, either the Bordered Five-Layer Foam Dressing and the Hydropolymer Foam Dressing, or the Bordered Five-Layer Foam Dressing and the Hydrocellular Multi-Layer Foam Dressing) using a cross-over (repeated measures) design, with a total of four study arms.
| Arm | Type | Receives |
|---|---|---|
| Five-layer vs Hydropolymer | Active comparator | Device: Bordered Five-Layer Foam Dressing, Device: Hydropolymer Foam DressingBordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks. |
| Hydropolymer vs Five-layer | Active comparator | Device: Bordered Five-Layer Foam Dressing, Device: Hydropolymer Foam DressingHydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks |
| Five-layer vs Hydrocellular | Active comparator | Device: Bordered Five-Layer Foam Dressing, Device: Hydrocellular Multi-Layer Foam DressingBordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks. |
| Hydrocellular vs Five-layer | Active comparator | Device: Bordered Five-Layer Foam Dressing, Device: Hydrocellular Multi-Layer Foam DressingFoam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
- Signed informed consent.
- Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
- Study subject must be available and able to visit the clinic weekly for the full 4-week period.
Key exclusion criteria (11 listed)
- Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
- Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
- Subject has any evidence of peripheral arterial disease (PAD).
- Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
- Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
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 |
|---|---|---|
| Bordered Five-Layer Foam DressingAlso: Five-layerBordered, five-layer, flexible foam dressing with soft silicone adhesive technology | Device | Five-layer vs Hydrocellular, Five-layer vs Hydropolymer, Hydrocellular vs Five-layer, Hydropolymer vs Five-layer |
| Hydropolymer Foam DressingAlso: HydropolymerHydropolymer, adhesive foam island dressing | Device | Five-layer vs Hydropolymer, Hydropolymer vs Five-layer |
| Hydrocellular Multi-Layer Foam DressingAlso: HydrocellularMulti-layered, hydrocellular foam dressing with silicone adhesive | Device | Five-layer vs Hydrocellular, Hydrocellular vs Five-layer |
Primary outcome
% of Participants With Equal or Better Rate of Dressing Durability
Time frame: 4 weeks
Dressing strike-through determined @ Wk1 Day 3\&7, and Wk3 Day 17\&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset. Contributing factors to strike-through: Saturation of dressing pad: * Inappropriate dressing type * Inappropriate dressing change freq. (i.e. more frequent changes required) * Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: * Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) * Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) * Patient interference w/ dressing Dressing design deficiency: * Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) * Insufficient adhesion * Insufficient conformability (i.e. ability to conform to body contours \& challenging anatomical wound locations)
% of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21
Time frame: Weeks 1 and 3
Intact dressing after 7 days wear time, assessed @ Wk1 Day7 \& Wk3 Day21 only. 1st week of dressing wear (Wks 1 \& 3) is critical for start of wound healing. Contributing factors to strike-through: Saturation of dressing pad: * Inappropriate dressing type * Inappropriate dressing change freq. (i.e. more frequent changes required) * Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: * Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) * Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) * Patient interference w/ dressing Dressing design deficiency: * Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) * Insufficient adhesion * Insufficient conformability (i.e. ability to conform to body contours \& challenging anatomical wound locations)
7 secondary outcomes
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer
Time frame: 4 weeks
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer
Time frame: 4 weeks
% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer
Time frame: 4 weeks
% of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings
Time frame: 4 weeks
% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation
Time frame: 4 weeks
% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both)
Time frame: 4 weeks
Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Oscar Alvarez principal investigator
Vascular and Wound Care Center, University Hospital, Newark, NJ, USA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing and Hydrocellular Multi-Layer Foam Dressing in people with Chronic Wound and Venous Leg Ulcer, run by Molnlycke Health Care AB at 5 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 4 inclusion and 11 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 1 Apr 2021). 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?
% of Participants With Equal or Better Rate of Dressing Durability (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 1 Apr 2021.