Diabetic Foot UlcerNCT03670225
Evaluating Clinical Acceptance of a NPWT Wound Care System
A study testing Invia Motion Endure in people with Diabetic Foot Ulcer and Pressure Injury, run by Medela AG at 1 site in United States.
Trial summary
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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 30 Jan 2020
- 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 within 72 hours of admission to burn center.
- Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries/pressure ulcer.
- 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 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
1 site in 1 country.
United States1 site
Joseph M. Still Research Foundation
Augusta, Georgia, 30909
About this study
Official title: Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
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 of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds 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
- 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
- Secondary Objectives
- To evaluate the ease of use from clinicians.
- To evaluate overall satisfaction from clinicians. C. Tertiary Objectives
- Adequate management of the exudate
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer
- Being tested
- Invia Motion Endure
- Medical subject headings
- Diabetic Foot, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invia Motion EndureDevice
NPWT Invia Motion Endure
| Study group | Role | What they receive |
|---|---|---|
| Invia Motion Endure | Other | Not described Receives: Device: Invia Motion Endure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds
Goal of the therapy will be defined by the physician according to initial assessment:
- 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
- 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 enrolment, when the goal of therapy is documented
Measured: 4 weeks
Secondary outcomes (1)
Evaluation of ease of use and satisfaction
A weekly survey will be obtained from the wound clinic staff members to determine ease of use and satisfaction
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 posted13 Sep 2018
- Study start16 Oct 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- non-randomized
- Masking
- None (open label)
- Enrolment
- 10 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
- Robert F Mullins, MD, Principal investigator, Joseph M. Still Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670225
- Sponsor's protocol ID
- HC1801
- Status last verified
- Mar 2020
- First submitted
- 7 Sep 2018
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.
PubMed 19903300Morrison Informatics, Inc. A comprehensive cost analysis of medicare home oxygen therapy: A study for the American Association for Homecare. June 27, 2006.
C. Marquardt et. al. "Negative pressure wound therapy using PHMB gauze for the management of postoperative subcutaneous surgical site infections" Coloproctology" 36:364-369, 2014
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- NCT03670225
- Acronym / sponsor ID
- HC1801
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medela AGIndustry (pharma, biotech, devices)
- Collaborators
- Joseph M. Still Research Foundation, Inc.
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 13 Sep 2018 (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.
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 of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds 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
- 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
- Secondary Objectives
- To evaluate the ease of use from clinicians.
- To evaluate overall satisfaction from clinicians. C. Tertiary Objectives
- Adequate management of the exudate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-randomized
| Arm | Type | Receives |
|---|---|---|
| Invia Motion Endure | Other | Device: Invia Motion Endure |
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 within 72 hours of admission to burn center.
- Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries/pressure ulcer.
- 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 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 EndureNPWT Invia Motion Endure | Device | Invia Motion Endure |
Primary outcome
Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds
Time frame: 4 weeks
Goal of the therapy will be defined by the physician according to initial assessment: * 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 * 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 enrolment, when the goal of therapy is documented
1 secondary outcome
Evaluation of ease of use and satisfaction
Time frame: 4 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 20 Mar 2020.
- Background: PubMed 19903300Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x.
- BackgroundMorrison Informatics, Inc. A comprehensive cost analysis of medicare home oxygen therapy: A study for the American Association for Homecare. June 27, 2006.
- BackgroundC. Marquardt et. al. "Negative pressure wound therapy using PHMB gauze for the management of postoperative subcutaneous surgical site infections" Coloproctology" 36:364-369, 2014
- 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.
Robert F Mullins, MD principal investigator
Joseph M. Still Research Foundation
1 site 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 in people with Diabetic Foot Ulcer and Pressure Injury, run by Medela AG at 1 site 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 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03670225, which also lists 3 linked publications.
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 20 Mar 2020.