Chronic Ulcer of Lower ExtremityPhase 2NCT04667416
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
A Phase 2 study testing PalinGen Flow Amniotic Tissue Allograft in people with Chronic Ulcer of Lower Extremity, run by Amnio Technology, LLC at 7 sites in United States.
Trial summary
The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ulcer of Lower Extremity
- What is being tested?
- PalinGen Flow Amniotic Tissue Allograft
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Jan 2021to 31 Jan 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read, understand and sign the informed consent form (ICF)
- Available and willing to complete all study assessments
- At least 12 weeks post lower extremity revascularization procedure, if one has been performed
- Have chronic ulcer(s) of the lower extremities with the following characteristics:
- Of diabetic or vascular etiology
- Duration of ≥4 weeks, unresponsive to SOC
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- ≤20 cm2 in area
- Extend through the full thickness of the skin but not down to muscle, tendon, or bone
- For subjects with VLU:
- Ulcer area is ≥1.5 cm2 and ≤20 cm2 and with a clean, granulating base with minimal adherent slough
- Ulcer location is at or above the ankle (malleolus) and below the knee
- Ulcer location is appropriate for use of compression therapy treatment
- For subjects with DFU:
- Ulcer area is ≥1.5 cm2 and ≤ 20 cm2 and is amenable to off-loading
- Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral/injectable medications to control blood glucose levels
- Glycosylated hemoglobin (HbA1c) level at screening is <12%
- Adequate circulation to the affected lower extremities
- Total serum bilirubin, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), hemoglobin, WBC, and PLT count all within limits specified in study protocol
- No renal impairment or mild renal impairment, defined as creatinine clearance ≥50 mL/min (by Cockroft-Gault estimation)
- Male subjects and female subjects of childbearing potential must use acceptable methods of contraception
Who cannot join
- Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials at the Baseline Visit
- Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable)
- Ulceration at the site of amputation
- Undergoing renal dialysis
- Known or suspected malignancy in the target ulcer, or a history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer)
- Documented history of osteomyelitis at the target ulcer location within 6 months of screening
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- Current treatment or anticipated need for treatment over the course of the study with:
- Immunosuppressants (including topical or systemic corticosteroids or glucocorticoids)
- Cytotoxic chemotherapy
- Growth hormone
- Oral or systemic antifungal or antituberculosis treatment
- History of radiation at the ulcer site
- New York Heart Association Class III or IV congestive heart failure or uncontrolled cardiac dysrhythmia
- Diagnosis of autoimmune disease(s) (rheumatoid arthritis, lupus, psoriasis, Sjogren's syndrome) or arthritis requiring corticosteroid treatment
- Target ulcer(s) previously treated with negative pressure, hyperbaric oxygen, or tissue engineered materials (eg, Apligraf®, EpiFix® or Dermagraft®) or other scaffold materials (eg, Oasis, Matristem) within 4 weeks prior to Screening Visit
- Target ulcer(s) anticipated to require negative pressure wound therapy or hyperbaric oxygen at any time during the study
- Subjects with VLU who have:
- Deep vein thrombosis diagnosed within 4 weeks prior to Screening Visit
- Refusal or inability to tolerate compression therapy
- Subjects with DFU who have:
- Active Charcot foot (stable chronic Charcot foot is not exclusionary)
- Ulcers on toes 2, 3, 4, and/or 5 only (ulcer on plantar surface of the great toe only is not exclusionary)
- Pregnant or breast feeding
- Allergic to DMSO
- Healing of target ulcer is observed to be ≥35% at the end of the Run-in Period (between Screening and Baseline Visits)
- Presence of any condition(s) which compromises the subject's ability to complete this study, including subjects with a known history of poor adherence to medical treatment
- Subjects who, in the opinion of the Investigator, are not able to comply with study requirements
- Treatment with an investigational drug(s) or device(s) within the 4 weeks preceding Screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Center for Clinical Research
Carmichael, California, 95608
Center for Clinical Research
Castro Valley, California, 94546
Acclaim Bone & Joint Institute and Plastic Surgery
Fort Worth, Texas, 76104
Limb Preservation Platform
Fresno, California, 93710
Futuro Clinical Trials
McAllen, Texas, 78501
Center for Clinical Research
San Francisco, California, 94115
ILD Research Center
Vista, California, 92083
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of PalinGen® Flow Amniotic Tissue Allograft to Assess Safety, Tolerability, and Preliminary Efficacy for the Treatment of Chronic Lower Extremity Cutaneous Ulcers Compared to Standard of Care
The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.
- Conditions
- Chronic Ulcer of Lower Extremity
- Being tested
- PalinGen Flow Amniotic Tissue Allograft
- Keywords
- Diabetic ulcer, Venous stasis ulcer
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalinGen Flow Amniotic Tissue AllograftBiological
Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | Participants will receive SOC for chronic ulcers of the lower extremities. |
| PalinGen Flow Treatment plus SOC | Experimental | Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC. Receives: Biological: PalinGen Flow Amniotic Tissue Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs)
Treatment-emergent adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and graded per the CTCAE Version 5.0.
Measured: All adverse events (AEs) and serious adverse events (SAEs) will be recorded from the time of signing of the informed consent form through Week 64.
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone who achieve complete ulcer closure by Week 12.
Complete wound closure will be assessed by the Bates-Jensen Wound Assessment Tool (BWAT) and a photographic imaging and measurement device.
Measured: BWAT assessment and wound imaging will be performed at each study visit through end of treatment (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start19 Jan 2021
- Primary completionMar 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ulcer of Lower ExtremityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amnio Technology, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph M Caporusso, D.P.M., Principal investigator, Futuro Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667416
- Sponsor's protocol ID
- PGF-201
- Status last verified
- Mar 2024
- First submitted
- 8 Dec 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of PalinGen® Flow Amniotic Tissue Allograft to Assess Safety, Tolerability, and Preliminary Efficacy for the Treatment of Chronic Lower Extremity Cutaneous Ulcers Compared to Standard of Care
- ClinicalTrials.gov ID
- NCT04667416
- Acronym / sponsor ID
- PGF-201
- Conditions
- Chronic Ulcer of Lower Extremity
- Keywords
- Diabetic ulcer, Venous stasis ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Amnio Technology, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 14 Dec 2020 (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.
The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | No intervention | –Participants will receive SOC for chronic ulcers of the lower extremities. |
| PalinGen Flow Treatment plus SOC | Experimental | Biological: PalinGen Flow Amniotic Tissue AllograftParticipants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Able to read, understand and sign the informed consent form (ICF)
- Available and willing to complete all study assessments
- At least 12 weeks post lower extremity revascularization procedure, if one has been performed
- Have chronic ulcer(s) of the lower extremities with the following characteristics:
- For subjects with VLU:
Key exclusion criteria (28 listed)
- Clinical evidence of ongoing infection and/or receipt of IV, oral, or topical antimicrobials at the Baseline Visit
- Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable)
- Ulceration at the site of amputation
- Undergoing renal dialysis
- Known or suspected malignancy in the target ulcer, or a history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer)
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 |
|---|---|---|
| PalinGen Flow Amniotic Tissue AllograftParticipants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC. | Biological | PalinGen Flow Treatment plus SOC |
Primary outcome
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs)
Time frame: All adverse events (AEs) and serious adverse events (SAEs) will be recorded from the time of signing of the informed consent form through Week 64.
Treatment-emergent adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and graded per the CTCAE Version 5.0.
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone who achieve complete ulcer closure by Week 12.
Time frame: BWAT assessment and wound imaging will be performed at each study visit through end of treatment (Week 12)
Complete wound closure will be assessed by the Bates-Jensen Wound Assessment Tool (BWAT) and a photographic imaging and measurement device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
Joseph M Caporusso, D.P.M. principal investigator
Futuro Clinical Trials
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PalinGen Flow Amniotic Tissue Allograft in people with Chronic Ulcer of Lower Extremity, run by Amnio Technology, LLC at 7 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 20 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs) (time frame: All adverse events (AEs) and serious adverse events (SAEs) will be recorded from the time of signing of the informed consent form through Week 64.). 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 20 Mar 2024.