Clinical trial NCT04667416: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Ulcer of Lower Extremity
Keywords: Diabetic ulcer
Venous stasis ulcer
Lead sponsor: Amnio Technology, LLC
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone with treatment-emergent adverse events (TEAEs)
timeFrame: 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.
measure: Proportion of participants in the PalinGen Flow plus SOC group versus SOC alone who achieve complete ulcer closure by Week 12.
timeFrame: BWAT assessment and wound imaging will be performed at each study visit through end of treatment (Week 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Carmichael
country: United States
facility: Center for Clinical Research
state: California
city: Castro Valley
country: United States
facility: Center for Clinical Research
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research
state: California
city: Vista
country: United States
facility: ILD Research Center
state: California
city: Fort Worth
country: United States
facility: Acclaim Bone & Joint Institute and Plastic Surgery
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials
state: Texas
Study officials:
affiliation: Futuro Clinical Trials
name: Joseph M Caporusso, D.P.M.
role: PRINCIPAL_INVESTIGATOR
References: