Back to resultsPuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
Primary Purpose
Chronic Pressure Ulcers
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PuraPly® Antimicrobial Wound Matrix
SOC for Pressure Ulcers
Sponsored by
About this trial
This is an interventional other trial for Chronic Pressure Ulcers focused on measuring Chronic wounds, PHMB, Pressure Ulcer, Wound Management, Collagen, Stage II, Stage III, Stage IV, Pressure Injury
Eligibility Criteria
Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
- Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area > 2cm2
- If multiple ulcers are present, one ulcer must be identified as the index ulcer.
- The index ulcer is free from active infection at the time of randomization.
- Willingness to off-load or pressure redistribute ulcer for duration of enrollment
- The index ulcer has been offloaded for at least 7 days prior to randomization.
- The index ulcer must have been present for at least 30 days at time of study enrollment.
- The index ulcer is separated at least 4 cm from all other ulcers at Study Day -7 and Study Day 0 (post-debridement) and has a margin of intact skin sufficient for anchoring of the required study dressing.
- Subject has read and signed the IRB/IEC approved Informed Consent Form (ICF) before screening procedures are undertaken.
Exclusion Criteria:
- Presence of signs and symptoms of infection at the index ulcer site, including but not limited to cellulitis, acute osteomyelitis, excessive exudate, gangrene or deep tissue infection
- The index ulcer is not free of necrotic tissue and is unable to tolerate debridement
- Non-enteric or unexplored sinus tract
- Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study
- Subject has a known sensitivity to porcine materials
- Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)
Sites / Locations
- Northwell Health
- NYU Winthrop Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PuraPly® AM plus Standard of Care
Standard of Care (SOC) for Pressure Ulcers
Arm Description
Outcomes
Primary Outcome Measures
Reduction in size of ulcer area between groups
As measured from change in size from baseline
Improvement in wound bed condition between groups
As measured from change in status from baseline
Secondary Outcome Measures
Time to complete wound closure between both groups
As measured by time to complete wound closure from baseline
Improvement in patient reported pain
As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
Improvement in patient reported quality of life
As measured by change in status from baseline as assessed by the Wound QoL (W-QoL), questionnaire on quality of life with chronic wounds
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03502824
Brief Title
PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
Official Title
A Prospective, Multicenter, Randomized, Controlled Clinical Study Of PuraPly® AM and Standard of Care (SOC) Compared to SOC Alone For The Management Of Stage II-IV Pressure Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organogenesis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure ulcers located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
Detailed Description
This study seeks to demonstrate how PuraPly® AM performs against standard of care in Stage II-IV Pressure Ulcers through a prospective randomized controlled study design.
Subjects may be enrolled for up to 24 weeks; if healing occurs prior to week 24, a follow up healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure and participation may continue up to 24 weeks. Subjects that are randomized to the SOC group have the opportunity to cross over and receive PuraPly AM at week 12 if their index ulcer has not healed; they will then be followed for an additional 12 weeks for up to 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pressure Ulcers
Keywords
Chronic wounds, PHMB, Pressure Ulcer, Wound Management, Collagen, Stage II, Stage III, Stage IV, Pressure Injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PuraPly® AM plus Standard of Care
Arm Type
Active Comparator
Arm Title
Standard of Care (SOC) for Pressure Ulcers
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PuraPly® Antimicrobial Wound Matrix
Other Intervention Name(s)
PuraPly® AM
Intervention Description
PuraPly® AM is a class II medical device, that has been 510(k) cleared by US Food and Drug Administration (FDA) (K051647) and is intended for the management of acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.
Intervention Type
Other
Intervention Name(s)
SOC for Pressure Ulcers
Intervention Description
SOC group will receive institutional standard of care which includes, but is not limited to, debridement, negative pressure wound therapy (i.e. VAC), ensuring perfusion and oxygenation, evaluating nutritional status and addressing deficits, offloading, keeping the ulcer bed moist with appropriate cleansing at the time of each dressing change. Standard dressings may include hydrocolloids, alginates, transparent film, foam, moist gauze dressings. In addition, a non-toxic topical antiseptic, may be used per NPUAP Clinical Practice Guidelines (2014) for SOC group only, if colonization is suspected.
Primary Outcome Measure Information:
Title
Reduction in size of ulcer area between groups
Description
As measured from change in size from baseline
Time Frame
Up to 24 weeks
Title
Improvement in wound bed condition between groups
Description
As measured from change in status from baseline
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Time to complete wound closure between both groups
Description
As measured by time to complete wound closure from baseline
Time Frame
Up to 24 weeks
Title
Improvement in patient reported pain
Description
As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
Time Frame
Up to 24 weeks
Title
Improvement in patient reported quality of life
Description
As measured by change in status from baseline as assessed by the Wound QoL (W-QoL), questionnaire on quality of life with chronic wounds
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be at least 18 years of age.
Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area > 2cm2
If multiple ulcers are present, one ulcer must be identified as the index ulcer.
The index ulcer is free from active infection at the time of randomization.
Willingness to off-load or pressure redistribute ulcer for duration of enrollment
The index ulcer has been offloaded for at least 7 days prior to randomization.
The index ulcer must have been present for at least 30 days at time of study enrollment.
The index ulcer is separated at least 4 cm from all other ulcers at Study Day -7 and Study Day 0 (post-debridement) and has a margin of intact skin sufficient for anchoring of the required study dressing.
Subject has read and signed the IRB/IEC approved Informed Consent Form (ICF) before screening procedures are undertaken.
Exclusion Criteria:
Presence of signs and symptoms of infection at the index ulcer site, including but not limited to cellulitis, acute osteomyelitis, excessive exudate, gangrene or deep tissue infection
The index ulcer is not free of necrotic tissue and is unable to tolerate debridement
Non-enteric or unexplored sinus tract
Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study
Subject has a known sensitivity to porcine materials
Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Gorenstein, MD FACEP
Organizational Affiliation
NYU Winthrop Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alisha Oropallo, MD, FACS, APWCA
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11402
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
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