Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human U… (NCT03818828) | Clinical Trial Compass
CompletedPhase 2
Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
United States31 participantsStarted 2019-02-14
Plain-language summary
It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot study provides a framework for a larger, controlled study. The purposes for conducting this study are to evaluate the functionality of the protocol and to obtain an estimate of product safety and efficacy when applied according to the protocol instructions, and measured according to the stated endpoints.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provide informed consent.
* Age ≥ 18 years and of either sex.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area in the range of ≥ 2.0 cm2 and ≤ 18.0 cm2 confirmed using the wound imaging and measurement device.
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Arterial supply adequacy confirmed by any one of the following: Great toe pressure ≥ 50 mm/Hg; Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ to 0.8 to ≤ 1.1; TcPO2 ≥ to 40 mmHg from the foot
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
* Target ulcer duration ≥ 6 weeks but ≤ 104 weeks
* For diabetic subjects an HbA1C \< 12.0% per the local lab report
Exclusion Criteria:
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
* Deep Vein Thrombosis (DVT) that is acute, defined as the first 10 days from onset of symptoms, or any DVT for which compression bandaging is considered by the Investigator to be contraindicated.
* Clinical evidence of ulcer bed infection as described in the Study Guide.
* Documented history …