Chronic Ulcer of Leg or FootMORGENNCT05632250
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
A study testing ConvaFoam in people with Chronic Ulcer of Leg or Foot and Pressure Injury, run by ConvaTec Inc. at 5 sites in United States.
Trial summary
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ulcer of Leg or Foot, Pressure Injury
- What is being tested?
- ConvaFoam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Apr 2023to 13 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients aged 18 years and over
- Patients able and willing to provide informed consent
- Patients with wounds with a duration of no less than 2 months and no more than 12 months
- Patients must be willing to complete the QoL (quality of life) questionnaires via a valid email address
- Patients with at least one, but no more than two of the same wound indications which would require dressing according to the stage of the wound:
- Chronic ulcers (Venous, arterial, mixed aetiology or diabetic foot ulcers)
- Pressure Injury Stage II or greater
- Patients must be willing to attend visits as per schedule in protocol
Who cannot join
- Patients with known allergies to any of the materials used in the dressing
- Patients with known malignant wounds
- Patients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
- Patients, who in the opinion of the Investigator, are considered as unsuitable for any other reason
- Patients with chronic conditions such as autoimmune disorders in an acute flare phase, which in the opinion of the investigator would directly impact wound healing, use of immunosuppressant medications may be allowed if they have been on a stable dose and regimen over the past three months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Foot and Ankle Specialists of the Mid-Atlantic
Hagerstown, Maryland, 21742
Hope Vascularity & Podiatry, PLLC
Houston, Texas, 77504
NYU Langone Health
Mineola, New York, 11501
Foot and Ankle Specialsts of the Mid-Atlantic
Raleigh, North Carolina, 20006
ProMedica Toledo Hospital
Toledo, Ohio, 43606
About this study
Official title: A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings in the Management of Indicated Chronic Wound Types.
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
Read the detailed description
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of Chronic leg ulcers (including diabetic foot ulcers) and Pressure Injuries (Grade II and above)
- Conditions
- Chronic Ulcer of Leg or Foot, Pressure Injury
- Being tested
- ConvaFoam
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConvaFoamDevice
Also called ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non Adhesive
ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. Patient's wounds will be assessed and a dressing from the above will be applied as part of their normal standard of care. The wounds will be assessed on a weekly basis for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ConvaFoam dressings | Other | All participants wounds will be assessed and allocated a dressing based upon the investigator's clinical judgement. They will receive either ConvaFoam Border, Silicone or Non-Adhesive for up to 12 weeks as part of their standard of care Receives: Device: ConvaFoam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.
This will be measured by:
Lack of strike through
Loss of edge seal/adherence,
Dressing leakage/seepage
Dislodgement
Need for dressing change
Measured: 12 weeks
Secondary outcomes (5)
To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use
Performance will be measured by documenting the progress of the wound through a weekly standard wound assessment where progression with be measured by changes to the wound healing status from deteriorating to static, static to improvement or improved to healed
Measured: 12 weeks
To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use
As part of the study schedule Health Care Professionals to complete a questionnaire at the end of study to assess:
Ease of use
Ease of removal ( Atraumatic)
Wear time (meets recommended guidelines in IFU)
Measured: 12 weeks
To measure the performance of ConvaFoam dressings in the management of chronic wounds from a patient perspective when used in accordance with the instructions for use
As part of the study schedule patients will be asked to complete a quality of life questionnaire on their first and final visit to measure:
Dressing comfort ( patient satisfied with dressing comfort and able to resume activities of daily living
Measured: 12 weeks
To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use
Any device related adverse events such as wound complications, maceration, blistering, breakdown of peri wound skin edges or changes to skin integrity will be documented and reported as per protocol
Measured: 12 weeks
To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use
Any device related adverse events such will be documented and reported as per protocol
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start10 Apr 2023
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ulcer of Leg or FootStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Post Market Clinical Follow Up Study
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerem Ozere, MD, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632250
- Sponsor's protocol ID
- WC-22-427
- Acronym
- MORGEN
- Status last verified
- Apr 2024
- First submitted
- 9 Nov 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings in the Management of Indicated Chronic Wound Types.
- ClinicalTrials.gov ID
- NCT05632250
- Acronym / sponsor ID
- MORGEN / WC-22-427
- Conditions
- Chronic Ulcer of Leg or Foot, Pressure Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
Detailed description
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of Chronic leg ulcers (including diabetic foot ulcers) and Pressure Injuries (Grade II and above)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Post Market Clinical Follow Up Study
| Arm | Type | Receives |
|---|---|---|
| ConvaFoam dressings | Other | Device: ConvaFoamAll participants wounds will be assessed and allocated a dressing based upon the investigator's clinical judgement. They will receive either ConvaFoam Border, Silicone or Non-Adhesive for up to 12 weeks as part of their standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18 years and over
- Patients able and willing to provide informed consent
- Patients with wounds with a duration of no less than 2 months and no more than 12 months
- Patients must be willing to complete the QoL (quality of life) questionnaires via a valid email address
- Patients with at least one, but no more than two of the same wound indications which would require dressing according to the stage of the wound:
Key exclusion criteria (5 listed)
- Patients with known allergies to any of the materials used in the dressing
- Patients with known malignant wounds
- Patients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
- Patients, who in the opinion of the Investigator, are considered as unsuitable for any other reason
- Patients with chronic conditions such as autoimmune disorders in an acute flare phase, which in the opinion of the investigator would directly impact wound healing, use of immunosuppressant medications may be allowed if they have been on a stable dose and regimen over the past three months
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 |
|---|---|---|
| ConvaFoamAlso: ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non AdhesiveConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. Patient's wounds will be assessed and a dressing from the above will be applied as part of their normal standard of care. The wounds will be assessed on a weekly basis for up to 12 weeks. | Device | ConvaFoam dressings |
Primary outcome
To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds.
Time frame: 12 weeks
This will be measured by: Lack of strike through Loss of edge seal/adherence, Dressing leakage/seepage Dislodgement Need for dressing change
5 secondary outcomes
To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use
Time frame: 12 weeks
To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use
Time frame: 12 weeks
To measure the performance of ConvaFoam dressings in the management of chronic wounds from a patient perspective when used in accordance with the instructions for use
Time frame: 12 weeks
To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use
Time frame: 12 weeks
To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- 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.
Kerem Ozere, MD study director
Medical Director
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConvaFoam in people with Chronic Ulcer of Leg or Foot and Pressure Injury, run by ConvaTec Inc. 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 8 inclusion and 5 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 30 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds. (time frame: 12 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 30 Apr 2024.