Clinical trial NCT03502824: 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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pressure Ulcers
Keywords: Chronic wounds
PHMB
Pressure Ulcer
Wound Management
Collagen
Stage II
Stage III
Stage IV
Pressure Injury
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2018-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reduction in size of ulcer area between groups
timeFrame: Up to 24 weeks
measure: Improvement in wound bed condition between groups
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Time to complete wound closure between both groups
timeFrame: Up to 24 weeks
measure: Improvement in patient reported pain
timeFrame: Up to 24 weeks
measure: Improvement in patient reported quality of life
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
Study officials:
affiliation: NYU Winthrop Hospital
name: Scott Gorenstein, MD FACEP
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: Alisha Oropallo, MD, FACS, APWCA
role: PRINCIPAL_INVESTIGATOR
References: