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Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections

Primary Purpose

Venous Reflux, Venous Insufficiency, Venous Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polidocanol
Sponsored by
ProMedica Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Reflux focused on measuring Sclerotherapy, Venous Ablation, Reflux, Insufficiency, Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who have saphenous vein reflux and a single venous ulcer of any size Exclusion Criteria: Patients with multiple venous ulcers

Sites / Locations

  • Jobst Vascular Institute, ProMedica Toledo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1: Combination Sclerotherapy & Ablation

Arm 2: Sclerotherapy Only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Baseline Ulcer Healing Rate
A measure of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
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 (%)
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 (%)
Baseline Ulcer Size (Length)
Measurement of the ulcer; Recorded in centimeters (cm)
Baseline Ulcer Size (Width)
Measurement of the ulcer; Recorded in centimeters (cm)
Baseline Ulcer Size (Surface Area)
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
Baseline Ulcer Size (Depth)
Measurement of the ulcer; Recorded in centimeters (cm)
Baseline Ulcer Size (Volume)
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
3 Month Ulcer Size (Length)
Measurement of the ulcer; Recorded in centimeters (cm)
3 Month Ulcer Size (Width)
Measurement of the ulcer; Recorded in centimeters (cm)
3 Month Ulcer Size (Surface Area)
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
3 Month Ulcer Size (Depth)
Measurement of the ulcer; Recorded in centimeters (cm)
3 Month Ulcer Size (Volume)
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
6 Month Ulcer Size (Length)
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Width)
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Surface Area)
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
6 Month Ulcer Size (Depth)
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Volume)
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
Baseline Clinical Evaluation
Clinical evaluation by the physician and assessment of the subject's symptoms
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 14, 2022
Last Updated
November 28, 2022
Sponsor
ProMedica Health System
Collaborators
Jobst Vascular Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05633277
Brief Title
Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections
Official Title
Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ProMedica Health System
Collaborators
Jobst Vascular Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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: 1. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Reflux, Venous Insufficiency, Venous Ulcer, Venous Disease
Keywords
Sclerotherapy, Venous Ablation, Reflux, Insufficiency, Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking Description
After randomization is selected, no masking is required for this study.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Combination Sclerotherapy & Ablation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm 2: Sclerotherapy Only
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Polidocanol
Other Intervention Name(s)
Radio Frequency Ablation, Endovenous Laser Ablation Therapy, Varithena, Venaseal, Sotradecol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Ulcer Healing Rate
Description
A measure of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
Time Frame
Start of Treatment (Baseline)
Title
3 Month Ulcer Healing Rate Change
Description
A measure in the change of the percentage of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
Time Frame
3 months following start of treatment
Title
6 Month Ulcer Healing Rate Change
Description
A measure in the change of the percentage of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
Time Frame
6 months following start of treatment
Title
Baseline Ulcer Size (Length)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
Start of Treatment (Baseline)
Title
Baseline Ulcer Size (Width)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
Start of Treatment (Baseline)
Title
Baseline Ulcer Size (Surface Area)
Description
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
Time Frame
Start of Treatment (Baseline)
Title
Baseline Ulcer Size (Depth)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
Start of Treatment (Baseline)
Title
Baseline Ulcer Size (Volume)
Description
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
Time Frame
Start of Treatment (Baseline)
Title
3 Month Ulcer Size (Length)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
3 months following start of treatment
Title
3 Month Ulcer Size (Width)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
3 months following start of treatment
Title
3 Month Ulcer Size (Surface Area)
Description
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
Time Frame
3 months following start of treatment
Title
3 Month Ulcer Size (Depth)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
3 months following start of treatment
Title
3 Month Ulcer Size (Volume)
Description
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
Time Frame
3 months following start of treatment
Title
6 Month Ulcer Size (Length)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
6 months following start of treatment
Title
6 Month Ulcer Size (Width)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
6 months following start of treatment
Title
6 Month Ulcer Size (Surface Area)
Description
Measurement of the ulcer; Recorded in centimeters squared (cm^2)
Time Frame
6 months following start of treatment
Title
6 Month Ulcer Size (Depth)
Description
Measurement of the ulcer; Recorded in centimeters (cm)
Time Frame
6 months following start of treatment
Title
6 Month Ulcer Size (Volume)
Description
Measurement of the ulcer; Recorded in centimeters cubed (cm^3)
Time Frame
6 months following start of treatment
Title
Baseline Clinical Evaluation
Description
Clinical evaluation by the physician and assessment of the subject's symptoms
Time Frame
Start of Treatment (Baseline)
Title
3 Month Clinical Evaluation; Change Assessment
Description
Clinical evaluation by the physician and assessment of the subject's symptoms; later assessed for change from the previous visit.
Time Frame
3 months following start of treatment
Title
6 Month Clinical Evaluation; Change Assessment
Description
Clinical evaluation by the physician and assessment of the subject's symptoms; later assessed for change from the previous 2 visits.
Time Frame
6 months following start of treatment
Title
Baseline_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym)
Description
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.
Time Frame
Start of Treatment (Baseline)
Title
3 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment
Description
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.
Time Frame
3 months following start of treatment
Title
6 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment
Description
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.
Time Frame
6 months following start of treatment
Title
Baseline_Venous Clinical Severity Score (VCSS)
Description
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.
Time Frame
Start of Treatment (Baseline)
Title
3 Month_Venous Clinical Severity Score (VCSS); Change Assessment)
Description
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.
Time Frame
3 months following start of treatment
Title
6 Month_Venous Clinical Severity Score (VCSS); Change Assessment
Description
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.
Time Frame
6 months following start of treatment
Secondary Outcome Measure Information:
Title
Number of Days to Healed Status
Description
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.
Time Frame
From Date of Randomization until the date of documented healed status, assessed up to 365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have saphenous vein reflux and a single venous ulcer of any size Exclusion Criteria: Patients with multiple venous ulcers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fedor Lurie, PhD, MD
Phone
419-291-5997
Email
fedor.lurie@promedica.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fedor Lurie, PhD, MD
Organizational Affiliation
ProMedica Health System
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jihad Abbas, MD
Organizational Affiliation
ProMedica Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jobst Vascular Institute, ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fedor Lurie, PhD, MD
Phone
419-291-5997
Email
fedor.lurie@promedica.org
First Name & Middle Initial & Last Name & Degree
Jihad Abbas, MD
First Name & Middle Initial & Last Name & Degree
Brett Aplin, MD
First Name & Middle Initial & Last Name & Degree
John Fish III, MD
First Name & Middle Initial & Last Name & Degree
Kate Gates, MD
First Name & Middle Initial & Last Name & Degree
Fedor Lurie, PhD, MD
First Name & Middle Initial & Last Name & Degree
Andrew Seiwert, MD, FACS

12. IPD Sharing Statement

Citations:
PubMed Identifier
12585831
Citation
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.
Results Reference
background
PubMed Identifier
18254024
Citation
O'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.
Results Reference
background
PubMed Identifier
15183623
Citation
Barwell 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.
Results Reference
background
PubMed Identifier
29688123
Citation
Gohel 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.
Results Reference
background
PubMed Identifier
24142137
Citation
Bush 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.
Results Reference
background
Links:
URL
https://www.uspharmacist.com/article/recognizing-and-treating-venous-stasis-ulcers
Description
Non-PubMed Citation: Terrie YC. Recognizing and Treating Venous Stasis Ulcers. US Pharm. 2017;42(2):36-39.
URL
https://www.hindawi.com/journals/ulcers/2013/413604/
Description
Non-PubMed Citation: Agale SV, (2013). Chronic leg ulcers: epidemiology, aetiopathogenesis, and management. Ulcers, 2013:413604.
URL
https://emedicine.medscape.com/article/1298345-overview
Description
Non-PubMed Citation: Gabriel A. Vascular ulcers. Medscape. http://emedicine.medscape.com/article/1298345-overview#a6. Accessed November 1, 2016.
URL
https://www.hmpgloballearningnetwork.com/site/podiatry/article/7071
Description
Non-PubMed Citation: Fishman TD, (2007). How to manage venous stasis ulcers. Podiatry Today. 20(5).

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Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections

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