Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)

Phase 2

Completed

Conditions: Venous Leg Ulcer

Interventions: Biological: TTAX01
Other: Profore Compression Therapy
Other: Cadexomer Iodine dressing

Registration Number: NCT03818828

Lead Sponsor: Tissue Tech Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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 of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
Refusal of or inability to tolerate compression therapy.
The subject is pregnant
The subject is a nursing mother
The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner).
Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the Screening Visit.
Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.
Current therapy with systemic antibiotics.
Current systemic therapy with cytotoxic drugs.
Current therapy with chronic (> 10 days) oral corticosteroids.
Current therapy with TNF alpha inhibitors other than Trental® (pentoxifylline).
History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
The subject has had previous use of NEOX® CORD 1K®, CLARIX® CORD 1K®, or TTAX01 applied to the index ulcer
The subject has an allergy to Amphotericin B or glycerol
The subject has an allergy to primary or secondary dressing materials used in this trial
Per Investigator's discretion the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments or the subject currently has sepsis, i.e., life-threatening organ dysfunction caused by a dysregulated host response to infection

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TTAX01	Profore Compression Therapy	TTAX01 will be applied directly to the wound surface and fixed with sterile adhesive strips, plus a secondary foam dressing held in place by multi-layer compression bandaging. A single layer of the test article should cover the entire open surface of the wound. TTAX01 may overlap onto adjacent healthy tissue and must be fenestrated prior to or after fixture. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case product will be withheld; or, if the test article has been accidentally dislodged within 1-week post application, it may be replaced at the subsequent treatment visit.
TTAX01	Cadexomer Iodine dressing	TTAX01 will be applied directly to the wound surface and fixed with sterile adhesive strips, plus a secondary foam dressing held in place by multi-layer compression bandaging. A single layer of the test article should cover the entire open surface of the wound. TTAX01 may overlap onto adjacent healthy tissue and must be fenestrated prior to or after fixture. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case product will be withheld; or, if the test article has been accidentally dislodged within 1-week post application, it may be replaced at the subsequent treatment visit.
TTAX01	TTAX01	TTAX01 will be applied directly to the wound surface and fixed with sterile adhesive strips, plus a secondary foam dressing held in place by multi-layer compression bandaging. A single layer of the test article should cover the entire open surface of the wound. TTAX01 may overlap onto adjacent healthy tissue and must be fenestrated prior to or after fixture. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case product will be withheld; or, if the test article has been accidentally dislodged within 1-week post application, it may be replaced at the subsequent treatment visit.

Primary Outcome Measures

Name	Time	Method
Complete wound healing	12-weeks	Proportion of subjects who achieve complete wound closure over the 12-week treatment period from baseline with a 4 week followup to confirm wound healing.

Secondary Outcome Measures

Name	Time	Method
Time to complete wound healing	up to 12 weeks	Time, in days, from baseline to initial observation of closure, in cases where healing is later confirmed.
Complete wound healing	up to 12 weeks	Proportion of subjects with complete wound closure at each of the 12 treatment weeks from baseline
Changes in pain using the numeric rating scale	up to 12 weeks	Change from baseline in pain level as reported using a numeric rating scale for the target ulcer and the affected leg, separately. Subjects will be asked to rate the level of pain they experience on a scale from 0 to 10, with 0 representing "no pain" and 10 representing "the worst possible pain".

Trial Locations

Locations (6): ILD Consulting, Inc.
🇺🇸
Carlsbad, California, United States
Rosalind Franklin University
🇺🇸
North Chicago, Illinois, United States
UCLA Olive View
🇺🇸
Sylmar, California, United States
Advanced Foot & Ankle Center
🇺🇸
Las Vegas, Nevada, United States
St Luke's-Roosevelt Hospital Center
🇺🇸
New York, New York, United States
Carilion Clinic
🇺🇸
Roanoke, Virginia, United States