VergenixTM Flowable Gel in Patients With Lower Limb Ulcers

Study Overview
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Brief Summary
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Vergenix Flowable Gel is indicated for the management of acute and chronic wounds

Detailed Description
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Vergenix™ Flowable Gel is an advanced wound care device primarily made of lyophilized Type I recombinant human Collagen (rhCollagen) . Vergenix Flowable Gel is supplied as a powder contained in a syringe that will be hydrated with saline, forming a gel. The Vergenix™ Flowable Gel provides a scaffold for cellular invasion and capillary growth. A secondary dressing to cover and secure the primary Vergenix™ Flowable Gel wound site followed by a final dressing application that will wrap the wound and surrounding area

Official Title
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Single Arm,Open Label Study, to Evaluate the Safety and Performance of VergenixTM Flowable Gel in Patients With Lower Limb Ulcers (CP-FG-001)

Conditions
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Lower Limb Ulcers

Intervention / Treatment
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* Device: VergenixTM Flowable Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years of age or older. 2. Patient has one of the following difficult-to-treat chronic ulcers in the lower limb: 2.1. Neuropathic lower limb ulcer 2.2. Venous lower limb ulcer 2.3. Post traumatic lower limb ulcer 2.4. Post operative lower limb ulcer 3. In case of Neuropathic foot grade according to University of Texas Classification 1A 4. Wound area measurement ranging between 1-20cm2. 5. Ulcer defined as grade ≥E on the granulometer scale. 6. Willing to adhere to the proper off-loading device (off loading cast, healing shoe) according to investigator recommendation. 7. Female patients must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or declare that they are abstaining from sexual intercourse, from the screening visit through the study termination visit or be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form. 8. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study. Exclusion Criteria: Acute ulcer Multiple Ulcers on the lower limb. Clinical evidence of infection in the soft tissue, joint and/or bone (osteomyelitis) as presented in the physical examination. The wound is penetrating into deep structures and involves bone, tendon or joint. Wound has necrotic tissue. Wound with sinus tracts. HbA1c>12. Patients with any other skin disorder unrelated to the ulcer that is presented in adjacent to the target wound. Clinically significant arterial vascular disease with Ankle-Brachial Index (ABI) index <0.45 if the peripheral pulse is not palpable, or flatted Pulse Volume Recording (PVR) in case of non palpable arteries. Patient is receiving, or has received within one month prior to enrollment any treatment known to impair wound healing, including but not limited to:, immunosuppressive drugs, cytotoxic agents, radiation therapy and chemotherapy. Has active malignant disease of any kind. A patient, who has had a malignant disease in the past, was treated and is currently disease-free for at least 5 years, may be considered for study entry. Patients who present with significant metabolic co-morbidity that would preclude wound healing such as end stage renal failure, dialysis or severe liver dysfunction. Clinically significant abnormalities in hematology and blood chemistry lab tests at screening that in the opinion of the investigator might interfere with the patient's safety or participation in the study. Known positive HIV. Known history of a significant medical disorder, which in the investigator's judgment contraindicates the patient's participation. Known hypersensitivity and/or allergy to collagen. Drug or alcohol abuse (by history). Patients participating in any other clinical trials. Patients with inability to communicate well with the investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VergenixTM Flowable Gel<br>VergenixTM Flowable Gel | Device: VergenixTM Flowable Gel<br>* The VergenixTM Flowable Gel is supplied as powder contained in a syringe that will be hydrated with saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound inspection | Wound inspection is a combination of measures that includes assessing the wound grade (according to Texas classification for Neuropathic ulcers only), wound's area and depth, presence of granulation tissue and the percentage of wound area covered with granulation, quality of the granulation tissue (granulometer scale), presence and location of epithelialization, presence of necrotic tissue and percentage of wound area covered with necrotic tissue, amount and quality of wound's secretions, presence of infection. | Change from baseline (day 0) to end of follow up (FU) period (week 4) | 
| Would Closure |  | Change from baseline (day 0) to end of follow up (FU) period (week 4) | 
| Pain Assessment | Pain will be assessed via VAS (Visual Analogue Scale) score | Change from baseline (day 0) to end of follow up (FU) period (week 4) | 
| Blood Chemistry and Hematology | The laboratory Blood Chemistry and Hematology tests will be aggregated to present the number of participants with abnormal laboratory values and/or Adverse Events that are related to treatment | Change from baseline (day 0) to end of follow up (FU) period (week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of Participants With Adverse Events That Are Related to Treatment | Change from baseline (day 0) to end of follow up (FU) period (week 4) |