Diabetic Foot UlcerNCT04593693
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
A study testing Invia Motion Endure NPWT system in people with Diabetic Foot Ulcer and Pressure Injury, run by Medela AG at 2 sites in United States.
Trial summary
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer
- What is being tested?
- Invia Motion Endure NPWT system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Dec 2020to 18 May 2021
- 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
- Adult subjects ≥18 years of age.
- Signed, informed consent by patient or LAR
- Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema
- Patient is comfortable (e.g. not in pain)
- Patient is willing and able to adhere to treatment protocol.
Who cannot join
- Patient not willing to comply with follow up (f/u) clinic visits
- Subjects with
- Necrotic tissue with eschar present
- Untreated osteomyelitis
- Non-enteric and unexplored fistulas
- Malignancy in wound
Show all 12Show fewer
- Exposed vasculature
- Exposed nerves
- Exposed anastomotic site of blood vessels or bypasses
- Exposed organs
- Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital
Augusta, Georgia, 30909
JMS Burn Centers, Inc. at Wellstar Cobb Hospital
Austell, Georgia, 30106
About this study
Official title: A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
Read the detailed description
The primary objective is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes when using the Medela Invia Motion Endure NPWT system during 4-week study duration.
- Goal of therapy will be defined by the physician according to initial assessment:
Endpoints (dependent on goal of therapy):
- Decrease in wound volume
- Decrease in size of the tunneling area
- Decrease in size of undermining
- Decrease in amount of slough
- Increase in granulation tissue
- Decrease in edema/periwound swelling
- The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.
Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound, Acute Wound, Traumatic Wound
- Being tested
- Invia Motion Endure NPWT system
- Keywords
- Negative Pressure Wound Therapy, Invia Motion
- Medical subject headings
- Diabetic Foot, Pressure Ulcer, Surgical Wound, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invia Motion Endure NPWT systemDevice
lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options
| Study group | Role | What they receive |
|---|---|---|
| Invia Motion Endure NPWT system | Other | Use of Negative Pressure Wound Thearpy Receives: Device: Invia Motion Endure NPWT system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal of therapy: Change in wound volume
Wound measurements will be performed each week and length, width and depth of the wound measured during treatment until goal of the therapy is reached
Measured: Up to 4 week study duration
Goal of therapy: Change in size of the tunneling area
Wound measurements will be performed each week and the tunneling of the wound measured during treatment until goal of the therapy is reached
Measured: Up to 4 week study duration
Goal of therapy: Change in size of undermining
Wound measurements will be performed each week and the undermining of the wound measured during treatment until goal of the therapy is reached
Measured: Up to 4 week study duration
Goal of therapy: Change in amount of slough
Wound measurements will be performed each week and the amount of slough measured during treatment until goal of the therapy is reached
Measured: Up to 4 week study duration
Goal of therapy: Change in granulation tissue
Wound measurements will be performed each week and the amount of granulation tissue measured during treatment until goal of the therapy is reached
Measured: Up to 4 week study duration
Goal of therapy: Change in edema/periwound swelling
Wound measurements will be performed each week and the presence of edema determined during treatment until goal of the therapy is reached
Measured: Up to 4 week study duration
Goal of therapy: The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft
Wound measurements will be performed each week and the wound bed visually determined during treatment until goal of the therapy is reached
Measured: Up to 4 week study duration
Secondary outcomes (2)
Evaluate the ease of use from clinicians
A weekly staff satisfaction survey will be obtained from the wound clinic staff members to determine ease of use on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied)
Measured: Up to 4 week study duration
Evaluate overall satisfaction from clinicians
A weekly staff satisfaction survey will be obtained from the wound clinic staff members to determine overall satisfaction with the device on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied)
Measured: Up to 4 week study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start10 Dec 2020
- Primary completion18 May 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medela AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joseph M. Still Research Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Claus Brandigi, MD, Principal investigator, Joseph M. Still Research Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593693
- Sponsor's protocol ID
- GHC1901
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2020
- Last updated
- 24 Sep 2021
- 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 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
- ClinicalTrials.gov ID
- NCT04593693
- Acronym / sponsor ID
- GHC1901
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound, Acute Wound, Traumatic Wound
- Keywords
- Negative Pressure Wound Therapy, Invia Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medela AGIndustry (pharma, biotech, devices)
- Collaborators
- Joseph M. Still Research Foundation, Inc.
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 20 Oct 2020 (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.
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
Detailed description
The primary objective is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes when using the Medela Invia Motion Endure NPWT system during 4-week study duration.
- Goal of therapy will be defined by the physician according to initial assessment:
Endpoints (dependent on goal of therapy):
- Decrease in wound volume
- Decrease in size of the tunneling area
- Decrease in size of undermining
- Decrease in amount of slough
- Increase in granulation tissue
- Decrease in edema/periwound swelling
- The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.
Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invia Motion Endure NPWT system | Other | Device: Invia Motion Endure NPWT systemUse of Negative Pressure Wound Thearpy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects ≥18 years of age.
- Signed, informed consent by patient or LAR
- Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema
- Patient is comfortable (e.g. not in pain)
- Patient is willing and able to adhere to treatment protocol.
Key exclusion criteria (12 listed)
- Patient not willing to comply with follow up (f/u) clinic visits
- Subjects with
- Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives
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 |
|---|---|---|
| Invia Motion Endure NPWT systemlightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options | Device | Invia Motion Endure NPWT system |
Primary outcome
Goal of therapy: Change in wound volume
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and length, width and depth of the wound measured during treatment until goal of the therapy is reached
Goal of therapy: Change in size of the tunneling area
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the tunneling of the wound measured during treatment until goal of the therapy is reached
Goal of therapy: Change in size of undermining
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the undermining of the wound measured during treatment until goal of the therapy is reached
Goal of therapy: Change in amount of slough
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the amount of slough measured during treatment until goal of the therapy is reached
Goal of therapy: Change in granulation tissue
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the amount of granulation tissue measured during treatment until goal of the therapy is reached
Goal of therapy: Change in edema/periwound swelling
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the presence of edema determined during treatment until goal of the therapy is reached
Goal of therapy: The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft
Time frame: Up to 4 week study duration
Wound measurements will be performed each week and the wound bed visually determined during treatment until goal of the therapy is reached
2 secondary outcomes
Evaluate the ease of use from clinicians
Time frame: Up to 4 week study duration
Evaluate overall satisfaction from clinicians
Time frame: Up to 4 week study duration
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 24 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Claus Brandigi, MD principal investigator
Joseph M. Still Research Foundation, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invia Motion Endure NPWT system in people with Diabetic Foot Ulcer and Pressure Injury, run by Medela AG at 2 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 5 inclusion and 12 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 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Goal of therapy: Change in wound volume (time frame: Up to 4 week study duration). The study lists 7 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 24 Sep 2021.