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

NCT03502824 | Terminated FDA Device

• 1 other identifier: 17-PRU-004-PPAM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pressure Ulcers

Keywords

Chronic wounds; PHMB; Pressure Ulcer; Wound Management; Collagen; Stage II; Stage III; Stage IV; Pressure Injury

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Time to complete wound closure between both groups

  Up to 24 weeks

• Improvement in patient reported pain

  Up to 24 weeks

• Improvement in patient reported quality of life

  Up to 24 weeks

Study Arms (2)

PuraPly® AM plus Standard of Care

ACTIVE COMPARATOR

Device: PuraPly® Antimicrobial Wound Matrix

Standard of Care (SOC) for Pressure Ulcers

ACTIVE COMPARATOR

Other: SOC for Pressure Ulcers

Interventions

PuraPly® Antimicrobial Wound Matrix DEVICE

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.

Also known as: PuraPly® AM

PuraPly® AM plus Standard of Care

SOC for Pressure Ulcers OTHER

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.

Standard of Care (SOC) for Pressure Ulcers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (2)

Northwell Health

Lake Success, New York, 11402, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Scott Gorenstein, MD FACEP

  NYU Winthrop Hospital

  PRINCIPAL INVESTIGATOR

• Alisha Oropallo, MD, FACS, APWCA

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 19, 2018
• Study Start: May 1, 2018
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

US (2)