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

Status unconfirmed · Phase 2

Conditions studied: Chronic Ulcer of Lower Extremity

In brief

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.

Key facts

Study ID

NCT04667416

Run by

Amnio Technology, LLC

People needed

82

Starts

2021-01-19

Expected to finish

2025-01-31

Last updated by the study team

2024-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

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
• 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)

Where it is running

• Center for Clinical Research — Carmichael, California, United States
• Center for Clinical Research — Castro Valley, California, United States
• Limb Preservation Platform — Fresno, California, United States
• Center for Clinical Research — San Francisco, California, United States
• ILD Research Center — Vista, California, United States
• Acclaim Bone & Joint Institute and Plastic Surgery — Fort Worth, Texas, United States
• Futuro Clinical Trials — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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