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

NCT07375160 | Not Yet Recruiting

• 1 other identifier: CELLBIO-2026-001
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Chronic Wound; Leg Wound; Amniotic; Allograft; Placenta

Outcome Measures

Primary Outcomes (1)

• Time to Closure for Target Ulcer

  To evaluate the time to wound closure for patients treated with dHPT.

  Up to 8 months.

Interventions

dHPT, AIC BIOLOGICAL

Sterile dehydrated Human Amnion - Intermediate Layer - Chorion Membrane Allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be drawn from wound clinic patient population that previously received treatment of their wound with a Cellution Biologics dHPT product

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cellution Biologics: lead

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer

Interventions

Aminoimidazole Carboxamide

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Bryanna Finstein

CONTACT

6035574660; bryanna.f@cellutionbiologics.com

Cellution Research

CONTACT

6035574660; clinical@cellutionbiologics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share