Chronic Pressure UlcersNCT03502824
PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
A study testing PuraPly® Antimicrobial Wound Matrix and SOC for Pressure Ulcers in people with Chronic Pressure Ulcers, run by Organogenesis at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Pressure Ulcers
- What is being tested?
- PuraPly® Antimicrobial Wound Matrix and SOC for Pressure Ulcers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2018to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwell Health
Lake Success, New York, 11402
NYU Winthrop Hospital
Mineola, New York, 11501
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pressure Ulcers
- Being tested
- PuraPly® Antimicrobial Wound Matrix, SOC for Pressure Ulcers
- Keywords
- Chronic wounds, PHMB, Pressure Ulcer, Wound Management, Collagen, Stage II, Stage III, Stage IV, Pressure Injury
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuraPly® Antimicrobial Wound MatrixDevice
Also called PuraPly® AM
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.
SOC for Pressure UlcersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PuraPly® AM plus Standard of Care | Active comparator | Not described Receives: Device: PuraPly® Antimicrobial Wound Matrix |
| Standard of Care (SOC) for Pressure Ulcers | Active comparator | Not described Receives: Other: SOC for Pressure Ulcers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in size of ulcer area between groups
As measured from change in size from baseline
Measured: Up to 24 weeks
Improvement in wound bed condition between groups
As measured from change in status from baseline
Measured: Up to 24 weeks
Secondary outcomes (3)
Time to complete wound closure between both groups
As measured by time to complete wound closure from baseline
Measured: Up to 24 weeks
Improvement in patient reported pain
As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
Measured: 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
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 May 2018
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Gorenstein, MD FACEP, Principal investigator, NYU Winthrop HospitalAlisha Oropallo, MD, FACS, APWCA, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502824
- Sponsor's protocol ID
- 17-PRU-004-PPAM
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2018
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03502824
- Acronym / sponsor ID
- 17-PRU-004-PPAM
- Conditions
- Chronic Pressure Ulcers
- Keywords
- Chronic wounds, PHMB, Pressure Ulcer, Wound Management, Collagen, Stage II, Stage III, Stage IV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 40 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PuraPly® Antimicrobial Wound MatrixAlso: PuraPly® AMPuraPly® 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. | Device | PuraPly® AM plus Standard of Care |
| SOC for Pressure UlcersSOC 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. | Other | Standard of Care (SOC) for Pressure Ulcers |
Primary outcome
Reduction in size of ulcer area between groups
Time frame: Up to 24 weeks
As measured from change in size from baseline
Improvement in wound bed condition between groups
Time frame: Up to 24 weeks
As measured from change in status from baseline
3 secondary outcomes
Time to complete wound closure between both groups
Time frame: Up to 24 weeks
Improvement in patient reported pain
Time frame: Up to 24 weeks
Improvement in patient reported quality of life
Time frame: Up to 24 weeks
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Gorenstein, MD FACEP principal investigator
NYU Winthrop Hospital
Alisha Oropallo, MD, FACS, APWCA principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PuraPly® Antimicrobial Wound Matrix and SOC for Pressure Ulcers in people with Chronic Pressure Ulcers, run by Organogenesis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in size of ulcer area between groups (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.