Status:
ACTIVE_NOT_RECRUITING
Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities
Lead Sponsor:
Amnio Technology, LLC
Conditions:
Chronic Ulcer of Lower Extremity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04667416
Start Date
January 19 2021
End Date
January 31 2025
Last Update
March 20 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Clinical Research
Carmichael, California, United States, 95608
2
Center for Clinical Research
Castro Valley, California, United States, 94546
3
Limb Preservation Platform
Fresno, California, United States, 93710
4
Center for Clinical Research
San Francisco, California, United States, 94115