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Clinical Trials in the USA / NCT07375160
Active, not recruiting Observational

Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing

NCT07375160 · tracked via the Priya Life Science USA tracker
Sponsor
Cellution Biologics
Phase
Observational
Started
2026-03-12
Last updated
2026-08-27

Condition(s) studied

Diabetic Foot Ulcer (DFU)Venous Leg Ulcer (VLU)Pressure Ulcer (PU)

Investigational drug(s) / intervention(s)

dHPT, AIC

dHPT, AIC: Sterile dehydrated Human Amnion - Intermediate Layer - Chorion Membrane Allograft

Study summary

The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years of age or older. * Wound treated with Cellution Biologics AmchoPlast, a dehydrated human placental tissue (dHPT). * Wound present for greater than or equal to 30 days prior to treatment with dHPT. * Wound is not infected. * Wound surface area is greater than 1cm2 at initial assessment. * Clinical documentation of wound treatment. Exclusion Criteria: * AmchoPlast dHPT product was not applied to wound. * HbA1C \>12%. * Presence of active osteomyelitis. * Concurrent treatment for malignant disease. * Use of other advanced biologics during treatment period.

Primary outcome measure(s)

  • Time to Closure for Target Ulcer — Up to 8 months.
    To evaluate the time to wound closure for patients treated with dHPT.

Trial sites (1)

FacilityCityRegionStatus
001 Chicago Illinois

More Cellution Biologics trials in the USA

Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover Enrolling by invitation

Other trials for the same condition

Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs Recruiting
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU Active, not recruiting
Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers Active, not recruiting
EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD Starting soon
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07375160 on ClinicalTrials.gov ↗ ← All trials in the USA