NCT03670225

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

September 7, 2018

Last Update Submit

March 19, 2020

Conditions

Diabetic Foot UlcerPressure InjuryPressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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\*\*

    4 weeks

Secondary Outcomes (1)

  • Evaluation of ease of use and satisfaction

    4 weeks

Other Outcomes (1)

  • Adequate management of the exudate

    4 weeks

Study Arms (1)

Invia Motion Endure

OTHER
Device: Invia Motion Endure

Interventions

Invia Motion EndureDEVICE

NPWT Invia Motion Endure

Invia Motion Endure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph M. Still Research Foundation

Augusta, Georgia, 30909, United States

Location

Related Publications (3)

  • 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.

    PMID: 19903300BACKGROUND

  • Morrison Informatics, Inc. A comprehensive cost analysis of medicare home oxygen therapy: A study for the American Association for Homecare. June 27, 2006.

    BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Diabetic FootPressure Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Robert F Mullins, MD

    Joseph M. Still Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: non-randomized
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 13, 2018

Study Start

October 16, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)