VergenixTM Flowable Gel in Patients With Lower Limb Ulcers

NCT ID: NCT02598180

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-25
• Study Completion Date: 2015-11-02

Brief Summary

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

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

Conditions

Lower Limb Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VergenixTM Flowable Gel

VergenixTM Flowable Gel

Group Type: EXPERIMENTAL

VergenixTM Flowable Gel

Intervention Type: DEVICE

The VergenixTM Flowable Gel is supplied as powder contained in a syringe that will be hydrated with saline.

Interventions

VergenixTM Flowable Gel

The VergenixTM Flowable Gel is supplied as powder contained in a syringe that will be hydrated with saline.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Collplant

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eran Tamir, MD

Role: PRINCIPAL_INVESTIGATOR

Maccabi Health Care

Locations

Maccabi Health Care

Beersheba, , Israel

Maccabi Health Care

Haifa, , Israel

Maccabi Health Care

Tel Aviv, , Israel

Assaf Harofeh

Zrifin, , Israel

Countries

Israel

Other Identifiers

CP-FG-001

Identifier Type: -

Identifier Source: org_study_id