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

NCT07230340 | Not Yet Recruiting Phase 4

• 1 other identifier: CELLBIO-2025-002
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.

Conditions

Venous Leg Ulcer (VLU)

Keywords

VLU; Venous Ulcer; Leg Wound; Venous Leg Ulcers (VLUs); Amniotic; Placenta; allograft

Outcome Measures

Primary Outcomes (1)

• Percentage of Venous Leg Ulcers with Complete Wound Closure

  The percentage of VLU target ulcers achieving complete wound closure. Closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.

  1-10 weeks

Secondary Outcomes (3)

• Time to Complete Closure for Ulcer

  1-10 weeks

• Percentage of Wound Area Change for Target Ulcer

  1-10 weeks

• Incidents of Adverse Events

  1-10 weeks

Other Outcomes (1)

• Changes in Pain Associated with the Target Ulcer

  1-10 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.

Procedure: Standard of Care (SOC)

AIC and Standard of Care

EXPERIMENTAL

Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.

Other: Amnion-Intermediate-Chorion; Procedure: Standard of Care (SOC)

Interventions

Amnion-Intermediate-Chorion OTHER

Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.

AIC and Standard of Care

Standard of Care (SOC) PROCEDURE

Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.

AIC and Standard of Care; Standard of Care

Eligibility Criteria

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

You may qualify if:

• Participants are required to meet all the following criteria for enrollment into the study:
• years of age or older.
• Hemoglobin A1c (HbA1c) level is \<12% (108 mmol/mol).
• Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization.
• Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit.
• Affected limb must have adequate perfusion confirmed by vascular assessment performed within 90 days of screening visit. Any of the following methods are acceptable:
• ABI ≥ 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic or triphasic.

You may not qualify if:

• The participant must agree to attend the weekly study visits required by the protocol.
• The participant must be willing and able to participate in the informed consent process
• Participants meeting any of the following criteria will be excluded from enrollment:
• Known life expectancy of \<6 months.
• Target ulcer is infected or there is cellulitis in the surrounding skin.
• Evidence of osteomyelitis complicating the target ulcer.
• Participant requires systemic antibiotic therapy or has used within the last 7 days.
• Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent), receiving cytotoxic chemotherapy, or taking medications that the investigator believes will interfere with wound healing (e.g., biologics).
• Topical application of steroids to the ulcer surface within 30 days of screening.
• Target ulcer exposes tendon or bone.
• Surface area of the target ulcer decreases by more than 20% during the 2-week screening phase.
• Mini Nutritional Assessment (MNA) score of less than 17.
• Participants of child bearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception.
• Currently requiring dialysis or planning to start within 6 months.
• Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.

Sponsors & Collaborators

• Cellution Biologics: lead

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Research Director

  Cellution Biologics

  STUDY DIRECTOR

Central Study Contacts

Bryanna Finstein

CONTACT

6035574660; bryanna.f@cellutionbiologics.com

Cellution Research

CONTACT

6035574660; clinical@cellutionbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share