PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pressure Ulcers
• Intervention / Treatment: Device: PuraPly® Antimicrobial Wound Matrix; Other: SOC for Pressure Ulcers

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Lake Success, New York, United States, 11402
      • Northwell Health
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
3. Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area > 2cm2
4. If multiple ulcers are present, one ulcer must be identified as the index ulcer.
5. The index ulcer is free from active infection at the time of randomization.
6. Willingness to off-load or pressure redistribute ulcer for duration of enrollment
7. The index ulcer has been offloaded for at least 7 days prior to randomization.
8. The index ulcer must have been present for at least 30 days at time of study enrollment.
9. 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.
10. Subject has read and signed the IRB/IEC approved Informed Consent Form (ICF) before screening procedures are undertaken.

Exclusion Criteria:

1. 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
2. The index ulcer is not free of necrotic tissue and is unable to tolerate debridement
3. Non-enteric or unexplored sinus tract
4. Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study
5. Subject has a known sensitivity to porcine materials
6. Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PuraPly® AM plus Standard of Care	Device: PuraPly® Antimicrobial Wound Matrix; 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.; Other Names: PuraPly® AM
Active Comparator: Standard of Care (SOC) for Pressure Ulcers	Other: SOC for Pressure Ulcers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in size of ulcer area between groups	As measured from change in size from baseline	Up to 24 weeks
Improvement in wound bed condition between groups	As measured from change in status from baseline	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in patient reported pain	As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)	Up to 24 weeks
Time to complete wound closure between both groups	As measured by time to complete wound closure from baseline	Up to 24 weeks
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	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Organogenesis
• Investigators: Principal Investigator: Scott Gorenstein, MD FACEP, NYU Winthrop Hospital; Principal Investigator: Alisha Oropallo, MD, FACS, APWCA, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Stage II; Stage III; PHMB; Collagen; Chronic wounds; Stage IV; Pressure Ulcer; Pressure Injury; Wound Management
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 17-PRU-004-PPAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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