Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07230340

PHASE4

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

Sponsor: Cellution Biologics

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers With Crossover for Subjects Randomized to Standard of Care

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01

Completion Date

2027-12

Last Updated

2025-12-16

Healthy Volunteers

Conditions

Venous Leg Ulcer (VLU)

Interventions

OTHER

Amnion-Intermediate-Chorion

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

PROCEDURE

Standard of Care (SOC)

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.

Inclusion Criteria: Participants are required to meet all the following criteria for enrollment into the study: 1. 18 years of age or older. 2. Hemoglobin A1c (HbA1c) level is \<12% (108 mmol/mol). 3. Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization. 4. Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit. 5. Affected limb must have adequate perfusion confirmed by vascular assessment performed within 90 days of screening visit. Any of the following methods are acceptable: 1. ABI ≥ 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic or triphasic. 6. If the participant has two or more ulcers, they must be separated by at least 2 cm post debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. 7. The participant must agree to attend the weekly study visits required by the protocol. 8. The participant must be willing and able to participate in the informed consent process Exclusion Criteria: Participants meeting any of the following criteria will be excluded from enrollment: 1. Known life expectancy of \<6 months. 2. Target ulcer is infected or there is cellulitis in the surrounding skin. 3. Evidence of osteomyelitis complicating the target ulcer. 4. Participant requires systemic antibiotic therapy or has used within the last 7 days. 5. 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). 6. Topical application of steroids to the ulcer surface within 30 days of screening. 7. Target ulcer exposes tendon or bone. 8. Surface area of the target ulcer decreases by more than 20% during the 2-week screening phase. 9. Mini Nutritional Assessment (MNA) score of less than 17. 10. 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. 11. Currently requiring dialysis or planning to start within 6 months. 12. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments. 13. Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit. 14. Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics. 15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.