VergenixTM Flowable Gel in Patients With Lower Limb Ulcers (CP-FG-001)

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

Vergenix Flowable Gel is indicated for the management of acute and chronic wounds

Study Overview

• Status: Completed
• Conditions: Lower Limb Ulcers
• Intervention / Treatment: Device: VergenixTM Flowable Gel

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer Sheva, Israel
    • Maccabi Health Care
  • Haifa, Israel
    • Maccabi Health Care
  • Tel Aviv, Israel
    • Maccabi Health Care
  • Zrifin, Israel
    • Assaf Harofeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Acute ulcer
2. Multiple Ulcers on the lower limb.

3. Clinical evidence of infection in the soft tissue, joint and/or bone

   (osteomyelitis) as presented in the physical examination.

4. The wound is penetrating into deep structures and involves bone,

   tendon or joint.

5. Wound has necrotic tissue.
6. Wound with sinus tracts.
7. HbA1c>12.

8. Patients with any other skin disorder unrelated to the ulcer that is

   presented in adjacent to the target wound.

9. 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.

10. 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.

11. 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.

12. Patients who present with significant metabolic co-morbidity that

    would preclude wound healing such as end stage renal failure, dialysis

    or severe liver dysfunction.

13. 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.

14. Known positive HIV.

15. Known history of a significant medical disorder, which in the

    investigator's judgment contraindicates the patient's participation.

16. Known hypersensitivity and/or allergy to collagen.
17. Drug or alcohol abuse (by history).
18. Patients participating in any other clinical trials.
19. Patients with inability to communicate well with the investigators and

staff (i.e., language problem, poor mental development or impaired

cerebral function).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Collplant
• Investigators: Principal Investigator: Eran Tamir, MD, Maccabi Health Care

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2014
• Primary Completion (Actual): November 2, 2015
• Study Completion (Actual): November 2, 2015

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer
• Other Study ID Numbers: CP-FG-001