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

Amnio Technology

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Ulcer of Lower Extremity

Treatments: Biological: PalinGen Flow Amniotic Tissue Allograft

Study type: Interventional

Funder types: Industry

Identifiers

NCT04667416

PGF-201

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Standard of Care (SOC)

No Intervention group

Description:

Participants will receive SOC for chronic ulcers of the lower extremities.

PalinGen Flow Treatment plus SOC

Experimental group

Description:

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

Treatment:

Biological: PalinGen Flow Amniotic Tissue Allograft