Lower Limb UlcersCP-FG-001NCT02598180
VergenixTM Flowable Gel in Patients With Lower Limb Ulcers
A study testing VergenixTM Flowable Gel in people with Lower Limb Ulcers, run by Collplant at 4 sites in Israel.
Trial summary
Vergenix Flowable Gel is indicated for the management of acute and chronic wounds Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Ulcers
- What is being tested?
- VergenixTM Flowable Gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesIsrael
- Study dates
- 25 Nov 2014to 2 Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Maccabi Health Care
Beersheba
Maccabi Health Care
Haifa
Maccabi Health Care
Tel Aviv
Assaf Harofeh
Zrifin
About this study
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)
Vergenix Flowable Gel is indicated for the management of acute and chronic wounds
Read the 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
- Being tested
- VergenixTM Flowable Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VergenixTM Flowable GelDevice
The VergenixTM Flowable Gel is supplied as powder contained in a syringe that will be hydrated with saline.
| Study group | Role | What they receive |
|---|---|---|
| VergenixTM Flowable Gel | Experimental | VergenixTM Flowable Gel Receives: Device: VergenixTM Flowable Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (day 0) to end of follow up (FU) period (week 4)
Would Closure
Measured: 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
Measured: 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
Measured: Change from baseline (day 0) to end of follow up (FU) period (week 4)
Secondary outcomes (1)
Adverse events
Number of Participants With Adverse Events That Are Related to Treatment
Measured: Change from baseline (day 0) to end of follow up (FU) period (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start25 Nov 2014
- Primary completion2 Nov 2015
- Study completion2 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collplant
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eran Tamir, MD, Principal investigator, Maccabi Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598180
- Sponsor's protocol ID
- CP-FG-001
- Acronym
- CP-FG-001
- Status last verified
- Feb 2019
- First submitted
- 22 Oct 2015
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02598180
- Acronym / sponsor ID
- CP-FG-001 / CP-FG-001
- Conditions
- Lower Limb Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CollplantIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2014 (actual)
- Primary completion
- 2 Nov 2015 (actual)
- Study completion
- 2 Nov 2015 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VergenixTM Flowable Gel | Experimental | Device: VergenixTM Flowable GelVergenixTM Flowable Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patient is 18 years of age or older.
- 2. Patient has one of the following difficult-to-treat chronic ulcers in the
- 2.1. Neuropathic lower limb ulcer
- 2.2. Venous lower limb ulcer
- 2.3. Post traumatic lower limb ulcer
Key exclusion criteria (36 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VergenixTM Flowable GelThe VergenixTM Flowable Gel is supplied as powder contained in a syringe that will be hydrated with saline. | Device | VergenixTM Flowable Gel |
Primary outcome
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.
Would Closure
Time frame: Change from baseline (day 0) to end of follow up (FU) period (week 4)
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
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
1 secondary outcome
Adverse events
Time frame: Change from baseline (day 0) to end of follow up (FU) period (week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eran Tamir, MD principal investigator
Maccabi Health Care
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VergenixTM Flowable Gel in people with Lower Limb Ulcers, run by Collplant at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound inspection (time frame: Change from baseline (day 0) to end of follow up (FU) period (week 4)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.