Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
Primary Purpose
Chronic Ulcer of Lower Extremity
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PalinGen Flow Amniotic Tissue Allograft
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Ulcer of Lower Extremity focused on measuring Diabetic ulcer, Venous stasis ulcer
Eligibility Criteria
Inclusion Criteria:
- 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
- ≤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
Exclusion Criteria:
- 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
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
Sites / Locations
- Center for Clinical ResearchRecruiting
- Center for Clinical ResearchRecruiting
- Limb Preservation PlatformRecruiting
- Center for Clinical ResearchRecruiting
- ILD Research CenterRecruiting
- Acclaim Bone & Joint Institute and Plastic SurgeryRecruiting
- Futuro Clinical TrialsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care (SOC)
PalinGen Flow Treatment plus SOC
Arm Description
Participants will receive SOC for chronic ulcers of the lower extremities.
Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04667416
First Posted
December 8, 2020
Last Updated
January 5, 2022
Sponsor
Amnio Technology, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04667416
Brief Title
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amnio Technology, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ulcer of Lower Extremity
Keywords
Diabetic ulcer, Venous stasis ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Arm Description
Participants will receive SOC for chronic ulcers of the lower extremities.
Arm Title
PalinGen Flow Treatment plus SOC
Arm Type
Experimental
Arm Description
Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.
Intervention Type
Biological
Intervention Name(s)
PalinGen Flow Amniotic Tissue Allograft
Intervention Description
Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.
Primary Outcome Measure Information:
Title
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs)
Description
Treatment-emergent adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and graded per the CTCAE Version 5.0.
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.
Title
Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone who achieve complete ulcer closure by Week 12.
Description
Complete wound closure will be assessed by the Bates-Jensen Wound Assessment Tool (BWAT) and a photographic imaging and measurement device.
Time Frame
BWAT assessment and wound imaging will be performed at each study visit through end of treatment (Week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
≤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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sponsor Regulatory Affairs Manager
Phone
888-232-8550
Email
quality@amniotechnology.com
Facility Information:
Facility Name
Center for Clinical Research
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irena Andreychenko
Phone
800-363-1069
Facility Name
Center for Clinical Research
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irena Andreychenko
Phone
916-459-4398
Facility Name
Limb Preservation Platform
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noe Guerrero
Phone
800-714-8011
Facility Name
Center for Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Peralta
Phone
800-363-1069
Facility Name
ILD Research Center
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Martinez
Phone
760-350-5080
Ext
6
Facility Name
Acclaim Bone & Joint Institute and Plastic Surgery
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April Bell
Phone
817-702-5362
Facility Name
Futuro Clinical Trials
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Rodriguez
Phone
956-999-8399
12. IPD Sharing Statement
Learn more about this trial
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
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