Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities

NCT04667416 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: PGF-201
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Ulcer of Lower Extremity

Keywords

Diabetic ulcer; Venous stasis ulcer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  BWAT assessment and wound imaging will be performed at each study visit through end of treatment (Week 12)

Study Arms (2)

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.

Biological: PalinGen Flow Amniotic Tissue Allograft

Interventions

PalinGen Flow Amniotic Tissue Allograft BIOLOGICAL

Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.

PalinGen Flow Treatment plus SOC

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amnio Technology, LLC: lead

Study Sites (7)

Center for Clinical Research

Carmichael, California, 95608, United States

Location

Center for Clinical Research

Castro Valley, California, 94546, United States

Location

Limb Preservation Platform

Fresno, California, 93710, United States

Location

Center for Clinical Research

San Francisco, California, 94115, United States

Location

ILD Research Center

Vista, California, 92083, United States

Location

Acclaim Bone & Joint Institute and Plastic Surgery

Fort Worth, Texas, 76104, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joseph M Caporusso, D.P.M.

  Futuro Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: January 19, 2021
• Primary Completion: March 1, 2024
• Study Completion: January 31, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (7)