VergenixTM Flowable Gel in Patients With Lower Limb Ulcers

NCT02598180 | Completed DMC

• 1 other identifier: CP-FG-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Lower Limb Ulcers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Adverse events

  Change from baseline (day 0) to end of follow up (FU) period (week 4)

Study Arms (1)

VergenixTM Flowable Gel

EXPERIMENTAL

VergenixTM Flowable Gel

Device: VergenixTM Flowable Gel

Interventions

VergenixTM Flowable Gel DEVICE

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

VergenixTM Flowable Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years of age or older.
• \. Patient has one of the following difficult-to-treat chronic ulcers in the
• lower limb:
• Neuropathic lower limb ulcer
• Venous lower limb ulcer
• Post traumatic lower limb ulcer
• Post operative lower limb ulcer
• \. In case of Neuropathic foot grade according to University of Texas
• Classification 1A
• \. Wound area measurement ranging between 1-20cm2.
• \. Ulcer defined as grade ≥E on the granulometer scale.
• \. Willing to adhere to the proper off-loading device (off loading cast,
• healing shoe) according to investigator recommendation.
• \. Female patients must have a negative serum pregnancy test at
• screening and be willing and able to use a medically acceptable

You may not qualify if:

• 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

Sponsors & Collaborators

• Collplant: lead

Study Sites (4)

Maccabi Health Care

Beersheba, Israel

Location

Maccabi Health Care

Haifa, Israel

Location

Maccabi Health Care

Tel Aviv, Israel

Location

Assaf Harofeh

Zrifin, Israel

Location

Study Officials

• Eran Tamir, MD

  Maccabi Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: November 5, 2015
• Study Start: November 25, 2014
• Primary Completion: November 2, 2015
• Study Completion: November 2, 2015
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

IL (4)