Evaluating Clinical Acceptance of a NPWT Wound Care System

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670225
• Other study ID #: HC1801
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2020
• Source: Medela AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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**

B. Secondary Objectives

• To evaluate the ease of use from clinicians.

• To evaluate overall satisfaction from clinicians. C. Tertiary Objectives

• Adequate management of the exudate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Crush Injuries
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Pressure Injury
• Pressure Ulcer
• Ulcer

Intervention

Device:
• Invia Motion Endure
NPWT Invia Motion Endure

Locations

Country	Name	City	State
United States	Joseph M. Still Research Foundation	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Medela AG	Joseph M. Still Research Foundation, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adequate management of the exudate	Measurament of exudate (ml, number of canisters used) will be performed	4 weeks
Primary	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	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	4 weeks