Leg UlcerPhase 4NCT02988063
Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in VLUs
A Phase 4 study testing Polidocanol Endovenous Microfoam (PEM) in people with Leg Ulcer and Veins, Varicose, run by OhioHealth at 1 site in United States.
Trial summary
This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in adults with severe venous disease of the great saphenous vein (GSV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer, Veins, Varicose, Venous Ulcer
- What is being tested?
- Polidocanol Endovenous Microfoam (PEM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 12 Sep 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Active VLU with a CEAP classification of C6
- Non-healing VLU ≥ 1 month but not greater than 24 months
- In the case of more than one ulcer, the largest ulcer (compliant with study criteria) will be chosen as the study ulcer and treated in the study. Other ulcerations, if present on the same leg must be at least 2cm apart from the study ulcer.
- Demonstrable GSV insufficiency (as per the Society for Vascular Surgery [SVS] and the American Venous Forum [AVF] Guidelines) via venous insufficiency study (VIS) (11)
- VLU considered non-healing (clinically defined as ≤70% wound improvement) after a 4-5 week run-in period with compression therapy
Show all 14Show fewer
- Venous leg ulcer size ≥ 2cm2 within the great saphenous distribution and must be visualized in one plane to allow for image collection of the entire wound in one photo by the Silhouette device.
- The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone
- The ulcer must be located below the knee
- The ulcer bed must have some viable tissues with some granulation tissue
- Able to tolerate effective compression bandaging
- Patients able to walk independently with or without mobility aids
- Ability to comprehend and sign an informed consent document and complete study questionnaires in English
- Able and willing to attend all follow up visits
Who cannot join
- Age < 18 years old
- Small saphenous vein (SSV) distribution VLUs
- Patients who had previously received interventions for underlying venous disease or prior VLU treatments that would not be considered to be conservative, in the opinion of the principal investigator
- Exposed bone, tendon, or fascia
- Deep vein reflux unless clinically insignificant in comparison to superficial reflux
- Patients with leg ulceration etiology other than venous insufficiency
Show all 33Show fewer
- Severe rheumatoid arthritis
- History of radiotherapy to the ulcer site
- Uncontrolled congestive heart failure (left or right sided heart failure)
- Receiving corticosteroids or immune suppressive therapy
- Active clinical infection of the ulcer site, however, patients may be entered into the study after successful treatment of infection
- History of collagen vascular disease
- History of known malnutrition (albumin <3.0 g/dL)
- History of known uncontrolled diabetes [hemoglobin A1c (HgbA1c) >8.0%]
- History of known arterial insufficiency [ankle-brachial index (ABI) <0.7, transcutaneous oxygen (tcpO2) <35 mmHg, or toe-brachial index (TBI) <0.4]
- Signs of cellulitis, osteomyelitis, or necrotic or avascular ulcer bed(s)
- Active sickle cell disease
- Patients diagnosed with DVT or phlebitis in the affected limb in the last 6 months, or with acute pulmonary embolism (PE) in the last 6 months (contraindication to PEM)
- Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions (contraindication to PEM)
- Chronic renal disease, if deemed by the principal investigator to be severe enough to interfere with wound healing
- Known active or recurrent cancer, or currently receiving chemotherapy or radiation therapy
- Poorly controlled asthma
- Pulmonary edema
- Major surgery, prolonged hospitalization, or pregnancy within 3 months of screening
- Minor surgery within 1 month of screening
- Current alcohol or drug (illicit or prescription) abuse
- Pregnant or lactating women
- History of stroke
- Unable to comply with the procedures described in the protocol
- Unable to comply with compression therapy recommendations
- Unable to give informed consent
- Non-English speaking
- Enrolled in a clinical evaluation for another investigational wound-care device or drug
Trial locations and contacts
1 site in 1 country.
United States1 site
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
About this study
Official title: Effect of Polidocanol Endovenous Microfoam (PEM) Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in Venous Leg Ulcers (VLUs)
This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in adults with severe venous disease of the great saphenous vein (GSV). All participants will receive treatment with Varithena and compression therapy.
The purpose of this study is to assess whether the use of PEM to correct superficial axial and varicose vein reflux is effective in improving healing of VLUs, over treatment with compression alone.
Read the detailed description
Compression therapy and polidocanol endovenous microfoam (PEM) are both used for the treatment of venous leg ulcers (VLUs), but they do so by different mechanisms.
Compression therapy applied by a wound care professional has been demonstrated to improve healing rates in patients with existing VLUs and to reduce ulcer recurrence, and is used consistently by treating physicians. Compression therapy consists of hosiery, tubular bandages and bandage systems comprising two or more components, which provide graduated compression to the lower limb in order to improve venous return and to reduce edema.
Polidocanol endovenous microfoam (PEM) is an injectable foam medication that is used to treat symptoms of venous disease, including venous leg ulcers (VLUs). The medication ("polidocanol") is in the foam ("endovenous microfoam"). PEM is injected through a catheter or by direct injection into the malfunctioning vein. The foam fills and treats the desired section of the vein, thereby collapsing the diseased vein. When the malfunctioning vein collapses, the microfoam is deactivated and blood flow shifts to healthier veins nearby.
- Conditions
- Leg Ulcer, Veins, Varicose, Venous Ulcer, Reflux, Venous Reflux, Venous Leg Ulcer
- Being tested
- Polidocanol Endovenous Microfoam (PEM)
- Keywords
- Varithena, Polidocanol Endovenous Microfoam
- Medical subject headings
- Leg Ulcer, Varicose Veins, Varicose Ulcer, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polidocanol Endovenous Microfoam (PEM)Drug
Also called Varithena
Polidocanol endovenous microfoam (PEM) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. PEM improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
| Study group | Role | What they receive |
|---|---|---|
| Compression plus PEM | Experimental | Patients will receive 4-5 weeks of compression therapy, followed by treatment with 1% polidocanol endovenous microfoam (PEM) and 12 additional weeks of compression therapy. If the treating physician determines that the vein is not closed after a subjective assessment of vein patency via standard-of-care limited duplex imaging, patients will be re-treated with PEM on Day 4. Receives: Drug: Polidocanol Endovenous Microfoam (PEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer healing rate
We will determine the change in ulcer healing rate following PEM treatment. Ulcer healing rate will be measured as the relative weekly change in ulcer perimeter (cm) from baseline, until either until fully healed, or up to the final active study visit at 12 weeks (whichever is sooner). Pre-treatment healing rate will be measured as the relative change in ulcer perimeter (cm) from baseline per week over the 4-5 week run-in period.
Measured: 12 weeks
Secondary outcomes (2)
Proportion of patients who successfully heal
We will determine the proportion of patients who successfully heal by 12 weeks. "Successful" healing will be defined as complete resolution of the ulcer (0 cm), with a lack of disruption of the epithelium at the ulcer site.
Measured: 12 weeks
Proportion of patients who experience symptomatic pulmonary embolism and deep vein thrombosis (PE and DVT, respectively) and other drug-related adverse events (AEs)
We will determine the proportion of patients who experience symptomatic pulmonary embolism and deep vein thrombosis (PE and DVT, respectively) and other drug-related adverse events (AEs) at 12 weeks (or the last active study visit if healed prior to 12 weeks). The most commonly reported drug-related AEs (occurring in ≥3% of patients) include pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, and superficial thrombophlebitis.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start10 Apr 2017
- Primary completion12 Sep 2017
- Study completion12 Sep 2017
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Collaborators
- BTG International Inc.
- Responsible party
- Principal investigator, Raghu Kolluri, OhioHealth
- Investigators
- Raghu Kolluri, MD, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988063
- Sponsor's protocol ID
- OH1-16-00664
- Status last verified
- Sep 2017
- First submitted
- 6 Dec 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polidocanol Endovenous Microfoam (PEM) Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in Venous Leg Ulcers (VLUs)
- ClinicalTrials.gov ID
- NCT02988063
- Acronym / sponsor ID
- OH1-16-00664
- Conditions
- Leg Ulcer, Veins, Varicose, Venous Ulcer, Reflux, Venous Reflux, Venous Leg Ulcer
- Keywords
- Varithena, Polidocanol Endovenous Microfoam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Collaborators
- BTG International Inc.
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 9 Dec 2016 (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.
This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in adults with severe venous disease of the great saphenous vein (GSV). All participants will receive treatment with Varithena and compression therapy.
The purpose of this study is to assess whether the use of PEM to correct superficial axial and varicose vein reflux is effective in improving healing of VLUs, over treatment with compression alone.
Detailed description
Compression therapy and polidocanol endovenous microfoam (PEM) are both used for the treatment of venous leg ulcers (VLUs), but they do so by different mechanisms.
Compression therapy applied by a wound care professional has been demonstrated to improve healing rates in patients with existing VLUs and to reduce ulcer recurrence, and is used consistently by treating physicians. Compression therapy consists of hosiery, tubular bandages and bandage systems comprising two or more components, which provide graduated compression to the lower limb in order to improve venous return and to reduce edema.
Polidocanol endovenous microfoam (PEM) is an injectable foam medication that is used to treat symptoms of venous disease, including venous leg ulcers (VLUs). The medication ("polidocanol") is in the foam ("endovenous microfoam"). PEM is injected through a catheter or by direct injection into the malfunctioning vein. The foam fills and treats the desired section of the vein, thereby collapsing the diseased vein. When the malfunctioning vein collapses, the microfoam is deactivated and blood flow shifts to healthier veins nearby.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compression plus PEM | Experimental | Drug: Polidocanol Endovenous Microfoam (PEM)Patients will receive 4-5 weeks of compression therapy, followed by treatment with 1% polidocanol endovenous microfoam (PEM) and 12 additional weeks of compression therapy. If the treating physician determines that the vein is not closed after a subjective assessment of vein patency via standard-of-care limited duplex imaging, patients will be re-treated with PEM on Day 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years old
- Active VLU with a CEAP classification of C6
- Non-healing VLU ≥ 1 month but not greater than 24 months
- In the case of more than one ulcer, the largest ulcer (compliant with study criteria) will be chosen as the study ulcer and treated in the study. Other ulcerations, if present on the same leg must be at least 2cm apart from the study ulcer.
- Demonstrable GSV insufficiency (as per the Society for Vascular Surgery [SVS] and the American Venous Forum [AVF] Guidelines) via venous insufficiency study (VIS) (11)
Key exclusion criteria (33 listed)
- Age < 18 years old
- Small saphenous vein (SSV) distribution VLUs
- Patients who had previously received interventions for underlying venous disease or prior VLU treatments that would not be considered to be conservative, in the opinion of the principal investigator
- Exposed bone, tendon, or fascia
- Deep vein reflux unless clinically insignificant in comparison to superficial reflux
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 |
|---|---|---|
| Polidocanol Endovenous Microfoam (PEM)Also: VarithenaPolidocanol endovenous microfoam (PEM) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. PEM improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. | Drug | Compression plus PEM |
Primary outcome
Ulcer healing rate
Time frame: 12 weeks
We will determine the change in ulcer healing rate following PEM treatment. Ulcer healing rate will be measured as the relative weekly change in ulcer perimeter (cm) from baseline, until either until fully healed, or up to the final active study visit at 12 weeks (whichever is sooner). Pre-treatment healing rate will be measured as the relative change in ulcer perimeter (cm) from baseline per week over the 4-5 week run-in period.
2 secondary outcomes
Proportion of patients who successfully heal
Time frame: 12 weeks
Proportion of patients who experience symptomatic pulmonary embolism and deep vein thrombosis (PE and DVT, respectively) and other drug-related adverse events (AEs)
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Leg Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
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.
Raghu Kolluri, MD principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polidocanol Endovenous Microfoam (PEM) in people with Leg Ulcer and Veins, Varicose, run by OhioHealth at 1 site in United States.
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 14 inclusion and 33 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: withdrawn, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Ulcer healing rate (time frame: 12 weeks). 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 15 Sep 2017.