Not Yet RecruitingPhase 4

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

70 participantsStarted 2026-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 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;

Exclusion criteria

✕. 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
✕. 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.

What they're measuring

Percentage of Venous Leg Ulcers with Complete Wound Closure

Timeframe: 1-10 weeks

Trial details

NCT IDNCT07230340

SponsorCellution Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Bryanna Finstein

6035574660 bryanna.f@cellutionbiologics.com

View on ClinicalTrials.gov More Venous Leg Ulcer (VLU) trials