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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02598180
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Collplant

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

Condition or disease Intervention/treatment Phase
Lower Limb Ulcers Device: VergenixTM Flowable Gel Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm,Open Label Study, to Evaluate the Safety and Performance of VergenixTM Flowable Gel in Patients With Lower Limb Ulcers (CP-FG-001)
Actual Study Start Date : November 25, 2014
Actual Primary Completion Date : November 2, 2015
Actual Study Completion Date : November 2, 2015

Arm Intervention/treatment
Experimental: VergenixTM Flowable Gel
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.




Primary Outcome Measures :
  1. Wound inspection [ Time Frame: Change from baseline (day 0) to end of follow up (FU) period (week 4) ]
    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.

  2. Would Closure [ Time Frame: Change from baseline (day 0) to end of follow up (FU) period (week 4) ]
  3. Pain Assessment [ Time Frame: Change from baseline (day 0) to end of follow up (FU) period (week 4) ]
    Pain will be assessed via VAS (Visual Analogue Scale) score

  4. Blood Chemistry and Hematology [ Time Frame: Change from baseline (day 0) to end of follow up (FU) period (week 4) ]
    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


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Change from baseline (day 0) to end of follow up (FU) period (week 4) ]
    Number of Participants With Adverse Events That Are Related to Treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598180


Locations
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Israel
Maccabi Health Care
Beer Sheva, Israel
Maccabi Health Care
Haifa, Israel
Maccabi Health Care
Tel Aviv, Israel
Assaf Harofeh
Zrifin, Israel
Sponsors and Collaborators
Collplant
Investigators
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Principal Investigator: Eran Tamir, MD Maccabi Health Care

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Responsible Party: Collplant
ClinicalTrials.gov Identifier: NCT02598180     History of Changes
Other Study ID Numbers: CP-FG-001
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Ulcer
Pathologic Processes