Venous RefluxNCT05633277
Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections
A study testing Polidocanol in people with Venous Reflux and Venous Insufficiency, run by ProMedica Health System at 1 site in United States.
Trial summary
Randomized Controlled Trial to determine if the outcomes of sclerotherapy of the ulcer bed alone differ from a combination of ablation and sclerotherapy injections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Reflux, Venous Insufficiency, Venous Ulcer
- What is being tested?
- Polidocanol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have saphenous vein reflux and a single venous ulcer of any size
Who cannot join
- Patients with multiple venous ulcers
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jobst Vascular Institute, ProMedica Toledo Hospital
Toledo, Ohio, 43606
Fedor Lurie, PhD, MD, 419-291-5997, fedor.lurie@promedica.org
Jihad Abbas, MD
About this study
Randomized Controlled Trial to determine if the outcomes of sclerotherapy of the ulcer bed alone differ from a combination of ablation and sclerotherapy injections.
Read the detailed description
Research Question:
Do outcomes of sclerotherapy of the ulcer bed alone, differ from a combination of ablation and injections?
Specific Aims:
Efficacy:
- To determine if receiving sclerotherapy and ablation along with compression therapy at the start of treatment (arm 1) has any benefit over receiving sclerotherapy at the start of treatment and ablation 3 months later along with compression therapy (arm 2) in the treatment of chronic venous ulcers.
- To compare and determine which arm has improved scores for quality of life (using the VEINES-QOL/Sym questionnaire).
- To compare and determine which arm has improved venous clinical severity scores (VCSS).
- To determine ulcer outcome and need for retreatment in arm 1 versus arm 2.
Safety:
- To determine which arm puts patients at greater risk of increased healing times in the treatment of chronic venous ulcers.
Methods:
Patients who are treated at Jobst Vascular Institute (JVI) will be evaluated for potential enrollment in this prospective study. Those who qualify, or their legally authorized representative (LAR), will be approached with study information and informed consent. Patients, or their LAR, who agree to participate will be consented and enrolled in the study.
This will be a randomized clinical trial. Subjects will be randomly allocated to each group. There will be roughly equal number of subjects in each arm. Arm 1 will be patients receiving sclerotherapy and ablation at the start of treatment along with compression therapy. The patients in arm 1 will not receive any further treatment during the duration of the study. Arm 2 will be patients who receive sclerotherapy at the start of treatment along with compression therapy, and ablation 3 months later. All patients in arm 2 will receive ablation at their 3 month appointment. After ablation, the patients in arm 2 will not receive any further treatment for the remainder of the study.
30 opaque envelopes, 15 indicating arm 1 and 15 indicating arm 2, will be prepared by the study coordinator. Patients who agree to participate will select an envelope and treatment will be initiated based off of the arm that is selected. In the event of a participants early termination from the study, up to 5 study participants will be replaced in each study arm to help ensure an adequate number of subjects for analysis. The purpose of this study is to see if one treatment is more effective over the other in treating chronic venous ulcers.
Patients who participate will have ultrasound-guided sclerosant injected into the affected area. Half of the patients will only receive injections (arm 2) while the other half of the patients will receive injections along with ablation (arm 1). Patients in arm 1 will not receive any further treatment during the remainder of the study. All patients will fill out a quality of life questionnaire (using the VEINES-QOL/Sym questionnaire) and complete the venous clinical severity score (VCSS) questionnaire prior to treatment. All patients will undergo compression therapy.
Patients will be seen weekly after treatment. Safety assessments will take place during these weekly appointments to ensure patient safety. After 3 months, patients will be brought in for another follow up visit. The 3 month follow up is considered standard protocol after these procedures to monitor for adverse events. Ulcer size, symptoms, healing rate, quality of life (using the VEINES-QOL/Sym questionnaire), and venous clinical severity score (VCSS) will be assessed. All patients in arm 2, will receive ablation at this time.
All patients will continue to be seen weekly to assess healing progress and to ensure patient safety. Six months following initial treatment, the patients will return for another follow up visit where ulcer size, symptoms, healing rate, quality of life (using the VEINES-QOL/Sym questionnaire), and VCSS will be assessed. Participation in the study will be complete after the 6 month follow up appointment. Patients will continue to see their physician for treatment, if needed, after their participation has concluded.
All treatments and appointments are considered standard of care and will be billed to the patients insurance.
Following completion of data collection (see study variables on attached excel sheet), analysis will be completed to identify study results. We will be analyzing the differences between the two groups in A. ulcer healing rate (comparison of means, generalized linear model), and B. proportion of healed ulcers (Chi square).
Number of Subjects:
Up to 40 subjects. The goal is to enroll 15 subjects in each arm. In the event of a participants early termination from the study, up to 5 study participants will be replaced in each study arm to help ensure an adequate number of subjects for analysis.
Background:
Venous ulcers are the most common cause of ulcerations that affect the lower extremities and are estimated to effect 1% of the American population. They are responsible for more than 80% of lower extremity ulcerations. Venous ulcers are most common in the elderly and in patients with a history of diabetes, obesity, varicose veins, blood clots, and edema of the lower extremities. Treatment is extensive averaging 6 to 12 months of continual therapy. Healing rates for these ulcers are poor and more than 50% of these types of ulcers are still unhealed after 9 months. Over 70% of those patients will end up developing another venous ulcer within 5 years. With these astounding numbers, it is imperative for early diagnosis and prompt treatment. Any underlying causes should also be assessed and determined at the time of diagnosis to help with healing and prevention.
Management of these ulcers has historically been compression treatment, stripping of the superficial veins, elevation of the effected leg, and exercise. Ablative superficial surgery along with compression is another form of treatment. Endovenous ablation is where the problematic vein is sealed off (generally the great saphenous vein (GSV) in the thigh or the short saphenous vein (SSV) behind the knee and calf). A catheter is fed up the vein from the ankle or knee level. It is carefully fed, using the aid of ultrasound, to the junction between the GSV and SSV. An electrical current or laser energy is passed through the vein wall causing the vein to contract and seal itself off. This procedure is quicker and less painful compared to the traditional operation of vein stripping. Early endovenous ablation of superficial venous reflux in addition to compression has resulted in shorter ulcer healing time and a reduction in the 12-month reoccurrence rate versus compression therapy alone.
Another popular form of treatment is sclerotherapy. Either a foam mixture or a solution is injected into the effected veins causing inflammation and scarring. Over time this leads to destruction of the veins. This treatment is also commonly used with compression therapy. This technique promotes rapid healing usually occurring within 4 to 8 weeks after the initial treatment and long term recurrence rates. This route is much less invasive, quicker, and less painful than the historical procedure of vein stripping.
Although there have been several studies performed on the significance of endovenous ablation and sclerotherapy, there is very little data or evidence to support the effectiveness of endovenous ablation in addition to sclerotherapy and compression in the treatment of venous ulcers and their reoccurrence. There is also very little data on whether receiving sclerotherapy and ablation together at the start of treatment, has any benefit over receiving sclerotherapy at the start of treatment and conducting ablation at a later time.
- Conditions
- Venous Reflux, Venous Insufficiency, Venous Ulcer, Venous Disease
- Being tested
- Polidocanol
- Keywords
- Sclerotherapy, Venous Ablation, Reflux, Insufficiency, Ulcer
- Medical subject headings
- Venous Insufficiency, Varicose Ulcer, Gastroesophageal Reflux, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolidocanolProcedure or surgery
Also called Radio Frequency Ablation, Endovenous Laser Ablation Therapy, Varithena, Venaseal
Sclerotherapy of the ulcer bed (polidocanol, sodium tetradecyl, etc) either in conjunction with a greater saphenous vein ablation treatment (RFA, EVLT, Venaseal, Varithena) at the same time or 3 months later.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Combination Sclerotherapy & Ablation | Active comparator | Standard Practice:
Arm 1 will be patients receiving sclerotherapy and ablation at the start of treatment along with compression therapy. The patients in arm 1 will not receive any further treatment during the duration of the study. Receives: Procedure: Polidocanol |
| Arm 2: Sclerotherapy Only | Experimental | Experimental Timeline:
Arm 2 will be patients who receive sclerotherapy at the start of treatment along with compression therapy, and ablation 3 months later. All patients in arm 2 will receive ablation at their 3 month appointment. After ablation, the patients in arm 2 will not receive any further treatment for the remainder of the study. Receives: Procedure: Polidocanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Ulcer Healing Rate
A measure of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
Measured: Start of Treatment (Baseline)
3 Month Ulcer Healing Rate Change
A measure in the change of the percentage of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
Measured: 3 months following start of treatment
6 Month Ulcer Healing Rate Change
A measure in the change of the percentage of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
Measured: 6 months following start of treatment
Baseline Ulcer Size (Length)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: Start of Treatment (Baseline)
Baseline Ulcer Size (Width)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: Start of Treatment (Baseline)
Baseline Ulcer Size (Surface Area)
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
Measured: Start of Treatment (Baseline)
Baseline Ulcer Size (Depth)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: Start of Treatment (Baseline)
Baseline Ulcer Size (Volume)
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
Measured: Start of Treatment (Baseline)
3 Month Ulcer Size (Length)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: 3 months following start of treatment
3 Month Ulcer Size (Width)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: 3 months following start of treatment
3 Month Ulcer Size (Surface Area)
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
Measured: 3 months following start of treatment
3 Month Ulcer Size (Depth)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: 3 months following start of treatment
3 Month Ulcer Size (Volume)
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
Measured: 3 months following start of treatment
6 Month Ulcer Size (Length)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: 6 months following start of treatment
6 Month Ulcer Size (Width)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: 6 months following start of treatment
6 Month Ulcer Size (Surface Area)
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
Measured: 6 months following start of treatment
6 Month Ulcer Size (Depth)
Measurement of the ulcer; Recorded in centimeters (cm)
Measured: 6 months following start of treatment
6 Month Ulcer Size (Volume)
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
Measured: 6 months following start of treatment
Baseline Clinical Evaluation
Clinical evaluation by the physician and assessment of the subject's symptoms
Measured: Start of Treatment (Baseline)
3 Month Clinical Evaluation; Change Assessment
Clinical evaluation by the physician and assessment of the subject's symptoms; later assessed for change from the previous visit.
Measured: 3 months following start of treatment
6 Month Clinical Evaluation; Change Assessment
Clinical evaluation by the physician and assessment of the subject's symptoms; later assessed for change from the previous 2 visits.
Measured: 6 months following start of treatment
Baseline_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym)
The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. Question scales range from 0 (minimum) to 6 (maximum) although values may vary based on the question. The total score for the VEINES-QOL/Sym questionnaire is based on a standardized score (T score). Lower scores are associated with more severe symptoms.
Measured: Start of Treatment (Baseline)
3 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment
The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. VEINES-QOL/Sym mean score distribution for each category (varying range, 0-6). VEINES-QOL/Sym total standardized score (Mean T-score) =50. Lower scores are associated with more severe symptoms.
Scores compared to the previous visit.
Measured: 3 months following start of treatment
6 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment
The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. VEINES-QOL/Sym mean score distribution for each category (varying range, 0-6). VEINES-QOL/Sym total standardized score (Mean T-score) =50. Lower scores are associated with more severe symptoms.
Scores compared to the previous 2 visits.
Measured: 6 months following start of treatment
Baseline_Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease.
Measured: Start of Treatment (Baseline)
3 Month_Venous Clinical Severity Score (VCSS); Change Assessment)
Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease. Change from Baseline scores compared at 3 months.
Measured: 3 months following start of treatment
6 Month_Venous Clinical Severity Score (VCSS); Change Assessment
Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease. Change from Baseline and 3 month scores compared at 6 months.
Measured: 6 months following start of treatment
Secondary outcomes (1)
Number of Days to Healed Status
Total number of days between date of initial treatment procedure [Arm 1/Arm 2] until date wound is considered healed, up to 365 days. If wound is not healed prior to end of time frame, or patient death occurs, an end date for this category will not be entered and the number of days not calculated.
Measured: From Date of Randomization until the date of documented healed status, assessed up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start30 Sep 2020
- Primary completionSep 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Venous RefluxStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Arm 1 will be patients receiving sclerotherapy and ablation at the start of treatment along with compression therapy. The patients in arm 1 will not receive any further treatment during the duration of the study. Arm 2 will be patients who receive sclerotherapy at the start of treatment along with compression therapy, and ablation 3 months later. All patients in arm 2 will receive ablation at their 3 month appointment. After ablation, the patients in arm 2 will not receive any further treatment for the remainder of the study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Jobst Vascular Institute
- Responsible party
- Principal investigator, Jihad Abbas, MD, ProMedica Health System
- Investigators
- Fedor Lurie, PhD, MD, Study director, ProMedica Health SystemJihad Abbas, MD, Principal investigator, ProMedica Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633277
- Sponsor's protocol ID
- 20-117
- Status last verified
- Nov 2022
- First submitted
- 14 Jul 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Araujo T, Valencia I, Federman DG, Kirsner RS. Managing the patient with venous ulcers. Ann Intern Med. 2003 Feb 18;138(4):326-34. doi: 10.7326/0003-4819-138-4-200302180-00012.
PubMed 12585831O'Meara S, Al-Kurdi D, Ovington LG. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003557. doi: 10.1002/14651858.CD003557.pub2.
PubMed 18254024Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
PubMed 15183623Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.
PubMed 29688123Bush R, Bush P. Percutaneous foam sclerotherapy for venous leg ulcers. J Wound Care. 2013 Oct;22(10 Suppl):S20-2. doi: 10.12968/jowc.2013.22.Sup10.S20.
PubMed 24142137
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections
- ClinicalTrials.gov ID
- NCT05633277
- Acronym / sponsor ID
- 20-117
- Conditions
- Venous Reflux, Venous Insufficiency, Venous Ulcer, Venous Disease
- Keywords
- Sclerotherapy, Venous Ablation, Reflux, Insufficiency, Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Collaborators
- Jobst Vascular Institute
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Dec 2022 (actual)
- 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.
Randomized Controlled Trial to determine if the outcomes of sclerotherapy of the ulcer bed alone differ from a combination of ablation and sclerotherapy injections.
Detailed description
Research Question:
Do outcomes of sclerotherapy of the ulcer bed alone, differ from a combination of ablation and injections?
Specific Aims:
Efficacy:
- To determine if receiving sclerotherapy and ablation along with compression therapy at the start of treatment (arm 1) has any benefit over receiving sclerotherapy at the start of treatment and ablation 3 months later along with compression therapy (arm 2) in the treatment of chronic venous ulcers.
- To compare and determine which arm has improved scores for quality of life (using the VEINES-QOL/Sym questionnaire).
- To compare and determine which arm has improved venous clinical severity scores (VCSS).
- To determine ulcer outcome and need for retreatment in arm 1 versus arm 2.
Safety:
- To determine which arm puts patients at greater risk of increased healing times in the treatment of chronic venous ulcers.
Methods:
Patients who are treated at Jobst Vascular Institute (JVI) will be evaluated for potential enrollment in this prospective study. Those who qualify, or their legally authorized representative (LAR), will be approached with study information and informed consent. Patients, or their LAR, who agree to participate will be consented and enrolled in the study.
This will be a randomized clinical trial. Subjects will be randomly allocated to each group. There will be roughly equal number of subjects in each arm. Arm 1 will be patients receiving sclerotherapy and ablation at the start of treatment along with compression therapy. The patients in arm 1 will not receive any further treatment during the duration of the study. Arm 2 will be patients who receive sclerotherapy at the start of treatment along with compression therapy, and ablation 3 months later. All patients in arm 2 will receive ablation at their 3 month appointment. After ablation, the patients in arm 2 will not receive any further treatment for the remainder of the study.
30 opaque envelopes, 15 indicating arm 1 and 15 indicating arm 2, will be prepared by the study coordinator. Patients who agree to participate will select an envelope and treatment will be initiated based off of the arm that is selected. In the event of a participants early termination from the study, up to 5 study participants will be replaced in each study arm to help ensure an adequate number of subjects for analysis. The purpose of this study is to see if one treatment is more effective over the other in treating chronic venous ulcers.
Patients who participate will have ultrasound-guided sclerosant injected into the affected area. Half of the patients will only receive injections (arm 2) while the other half of the patients will receive injections along with ablation (arm 1). Patients in arm 1 will not receive any further treatment during the remainder of the study. All patients will fill out a quality of life questionnaire (using the VEINES-QOL/Sym questionnaire) and complete the venous clinical severity score (VCSS) questionnaire prior to treatment. All patients will undergo compression therapy.
Patients will be seen weekly after treatment. Safety assessments will take place during these weekly appointments to ensure patient safety. After 3 months, patients will be brought in for another follow up visit. The 3 month follow up is considered standard protocol after these procedures to monitor for adverse events. Ulcer size, symptoms, healing rate, quality of life (using the VEINES-QOL/Sym questionnaire), and venous clinical severity score (VCSS) will be assessed. All patients in arm 2, will receive ablation at this time.
All patients will continue to be seen weekly to assess healing progress and to ensure patient safety. Six months following initial treatment, the patients will return for another follow up visit where ulcer size, symptoms, healing rate, quality of life (using the VEINES-QOL/Sym questionnaire), and VCSS will be assessed. Participation in the study will be complete after the 6 month follow up appointment. Patients will continue to see their physician for treatment, if needed, after their participation has concluded.
All treatments and appointments are considered standard of care and will be billed to the patients insurance.
Following completion of data collection (see study variables on attached excel sheet), analysis will be completed to identify study results. We will be analyzing the differences between the two groups in A. ulcer healing rate (comparison of means, generalized linear model), and B. proportion of healed ulcers (Chi square).
Number of Subjects:
Up to 40 subjects. The goal is to enroll 15 subjects in each arm. In the event of a participants early termination from the study, up to 5 study participants will be replaced in each study arm to help ensure an adequate number of subjects for analysis.
Background:
Venous ulcers are the most common cause of ulcerations that affect the lower extremities and are estimated to effect 1% of the American population. They are responsible for more than 80% of lower extremity ulcerations. Venous ulcers are most common in the elderly and in patients with a history of diabetes, obesity, varicose veins, blood clots, and edema of the lower extremities. Treatment is extensive averaging 6 to 12 months of continual therapy. Healing rates for these ulcers are poor and more than 50% of these types of ulcers are still unhealed after 9 months. Over 70% of those patients will end up developing another venous ulcer within 5 years. With these astounding numbers, it is imperative for early diagnosis and prompt treatment. Any underlying causes should also be assessed and determined at the time of diagnosis to help with healing and prevention.
Management of these ulcers has historically been compression treatment, stripping of the superficial veins, elevation of the effected leg, and exercise. Ablative superficial surgery along with compression is another form of treatment. Endovenous ablation is where the problematic vein is sealed off (generally the great saphenous vein (GSV) in the thigh or the short saphenous vein (SSV) behind the knee and calf). A catheter is fed up the vein from the ankle or knee level. It is carefully fed, using the aid of ultrasound, to the junction between the GSV and SSV. An electrical current or laser energy is passed through the vein wall causing the vein to contract and seal itself off. This procedure is quicker and less painful compared to the traditional operation of vein stripping. Early endovenous ablation of superficial venous reflux in addition to compression has resulted in shorter ulcer healing time and a reduction in the 12-month reoccurrence rate versus compression therapy alone.
Another popular form of treatment is sclerotherapy. Either a foam mixture or a solution is injected into the effected veins causing inflammation and scarring. Over time this leads to destruction of the veins. This treatment is also commonly used with compression therapy. This technique promotes rapid healing usually occurring within 4 to 8 weeks after the initial treatment and long term recurrence rates. This route is much less invasive, quicker, and less painful than the historical procedure of vein stripping.
Although there have been several studies performed on the significance of endovenous ablation and sclerotherapy, there is very little data or evidence to support the effectiveness of endovenous ablation in addition to sclerotherapy and compression in the treatment of venous ulcers and their reoccurrence. There is also very little data on whether receiving sclerotherapy and ablation together at the start of treatment, has any benefit over receiving sclerotherapy at the start of treatment and conducting ablation at a later time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1 will be patients receiving sclerotherapy and ablation at the start of treatment along with compression therapy. The patients in arm 1 will not receive any further treatment during the duration of the study. Arm 2 will be patients who receive sclerotherapy at the start of treatment along with compression therapy, and ablation 3 months later. All patients in arm 2 will receive ablation at their 3 month appointment. After ablation, the patients in arm 2 will not receive any further treatment for the remainder of the study.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Combination Sclerotherapy & Ablation | Active comparator | Procedure: PolidocanolStandard Practice: Arm 1 will be patients receiving sclerotherapy and ablation at the start of treatment along with compression therapy. The patients in arm 1 will not receive any further treatment during the duration of the study. |
| Arm 2: Sclerotherapy Only | Experimental | Procedure: PolidocanolExperimental Timeline: Arm 2 will be patients who receive sclerotherapy at the start of treatment along with compression therapy, and ablation 3 months later. All patients in arm 2 will receive ablation at their 3 month appointment. After ablation, the patients in arm 2 will not receive any further treatment for the remainder of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have saphenous vein reflux and a single venous ulcer of any size
Key exclusion criteria (1 listed)
- Patients with multiple venous ulcers
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 |
|---|---|---|
| PolidocanolAlso: Radio Frequency Ablation, Endovenous Laser Ablation Therapy, Varithena, VenasealSclerotherapy of the ulcer bed (polidocanol, sodium tetradecyl, etc) either in conjunction with a greater saphenous vein ablation treatment (RFA, EVLT, Venaseal, Varithena) at the same time or 3 months later. | Procedure or surgery | Arm 1: Combination Sclerotherapy & Ablation, Arm 2: Sclerotherapy Only |
Primary outcome
Baseline Ulcer Healing Rate
Time frame: Start of Treatment (Baseline)
A measure of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
3 Month Ulcer Healing Rate Change
Time frame: 3 months following start of treatment
A measure in the change of the percentage of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
6 Month Ulcer Healing Rate Change
Time frame: 6 months following start of treatment
A measure in the change of the percentage of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
Baseline Ulcer Size (Length)
Time frame: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters (cm)
Baseline Ulcer Size (Width)
Time frame: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters (cm)
Baseline Ulcer Size (Surface Area)
Time frame: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
Baseline Ulcer Size (Depth)
Time frame: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters (cm)
Baseline Ulcer Size (Volume)
Time frame: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
3 Month Ulcer Size (Length)
Time frame: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
3 Month Ulcer Size (Width)
Time frame: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
3 Month Ulcer Size (Surface Area)
Time frame: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
3 Month Ulcer Size (Depth)
Time frame: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
3 Month Ulcer Size (Volume)
Time frame: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
6 Month Ulcer Size (Length)
Time frame: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Width)
Time frame: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Surface Area)
Time frame: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
6 Month Ulcer Size (Depth)
Time frame: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Volume)
Time frame: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
Baseline Clinical Evaluation
Time frame: Start of Treatment (Baseline)
Clinical evaluation by the physician and assessment of the subject's symptoms
3 Month Clinical Evaluation; Change Assessment
Time frame: 3 months following start of treatment
Clinical evaluation by the physician and assessment of the subject's symptoms; later assessed for change from the previous visit.
6 Month Clinical Evaluation; Change Assessment
Time frame: 6 months following start of treatment
Clinical evaluation by the physician and assessment of the subject's symptoms; later assessed for change from the previous 2 visits.
Baseline_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym)
Time frame: Start of Treatment (Baseline)
The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. Question scales range from 0 (minimum) to 6 (maximum) although values may vary based on the question. The total score for the VEINES-QOL/Sym questionnaire is based on a standardized score (T score). Lower scores are associated with more severe symptoms.
3 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment
Time frame: 3 months following start of treatment
The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. VEINES-QOL/Sym mean score distribution for each category (varying range, 0-6). VEINES-QOL/Sym total standardized score (Mean T-score) =50. Lower scores are associated with more severe symptoms. Scores compared to the previous visit.
6 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment
Time frame: 6 months following start of treatment
The Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINS-QOL/Sym) Questionnaire measures the impact of CVI on symptoms and quality of life from the patient's perspective. It is an instrument with 26 items divided across eight questions. VEINES-QOL/Sym mean score distribution for each category (varying range, 0-6). VEINES-QOL/Sym total standardized score (Mean T-score) =50. Lower scores are associated with more severe symptoms. Scores compared to the previous 2 visits.
Baseline_Venous Clinical Severity Score (VCSS)
Time frame: Start of Treatment (Baseline)
Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease.
3 Month_Venous Clinical Severity Score (VCSS); Change Assessment)
Time frame: 3 months following start of treatment
Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease. Change from Baseline scores compared at 3 months.
6 Month_Venous Clinical Severity Score (VCSS); Change Assessment
Time frame: 6 months following start of treatment
Venous Clinical Severity Score (VCSS) are scored individually. VCSS mean score distribution for each category (range, 0-3). Higher scores are associated with more severe symptoms and disease. Change from Baseline and 3 month scores compared at 6 months.
1 secondary outcome
Number of Days to Healed Status
Time frame: From Date of Randomization until the date of documented healed status, assessed up to 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Background: PubMed 12585831de Araujo T, Valencia I, Federman DG, Kirsner RS. Managing the patient with venous ulcers. Ann Intern Med. 2003 Feb 18;138(4):326-34. doi: 10.7326/0003-4819-138-4-200302180-00012.
- Background: PubMed 18254024O'Meara S, Al-Kurdi D, Ovington LG. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003557. doi: 10.1002/14651858.CD003557.pub2.
- Background: PubMed 15183623Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
- Background: PubMed 29688123Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.
- Background: PubMed 24142137Bush R, Bush P. Percutaneous foam sclerotherapy for venous leg ulcers. J Wound Care. 2013 Oct;22(10 Suppl):S20-2. doi: 10.12968/jowc.2013.22.Sup10.S20.
- Non-PubMed Citation: Terrie YC. Recognizing and Treating Venous Stasis Ulcers. US Pharm. 2017;42(2):36-39.Link provided by the sponsor.
- Non-PubMed Citation: Gabriel A. Vascular ulcers. Medscape. http://emedicine.medscape.com/article/1298345-overview#a6. Accessed November 1, 2016.Link provided by the sponsor.
- Non-PubMed Citation: Fishman TD, (2007). How to manage venous stasis ulcers. Podiatry Today. 20(5).Link provided by the sponsor.
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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.
Fedor Lurie, PhD, MD study director
ProMedica Health System
Jihad Abbas, MD principal investigator
ProMedica Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polidocanol in people with Venous Reflux and Venous Insufficiency, run by ProMedica Health System 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Dec 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fedor Lurie, PhD, MD (419-291-5997, fedor.lurie@promedica.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Ulcer Healing Rate (time frame: Start of Treatment (Baseline)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05633277, which also lists 5 linked publications.
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 1 Dec 2022.