Outcomes of Sclerotherapy of the Ulcer Bed Compared to a Combination of Ablation and Injections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Baseline Ulcer Healing Rate
研究概览
简要总结
Randomized Controlled Trial to determine if the outcomes of sclerotherapy of the ulcer bed alone differ from a combination of ablation and sclerotherapy injections.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
After randomization is selected, no masking is required for this study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have saphenous vein reflux and a single venous ulcer of any size
排除标准
- •Patients with multiple venous ulcers
研究组 & 干预措施
Arm 2: Sclerotherapy Only
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.
干预措施: Polidocanol (Procedure)
Arm 1: Combination Sclerotherapy & Ablation
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.
干预措施: Polidocanol (Procedure)
结局指标
主要结局
Baseline Ulcer Healing Rate
时间窗: Start of Treatment (Baseline)
A measure of initial wound area as determined based on the ulcer size measurements collected; Recorded in Percentage (%)
6 Month Ulcer Healing Rate Change
时间窗: 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 (%)
3 Month Ulcer Size (Surface Area)
时间窗: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters squared (cm\^2)
Baseline Ulcer Size (Depth)
时间窗: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters (cm)
3 Month Ulcer Size (Width)
时间窗: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
3 Month Ulcer Size (Volume)
时间窗: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters cubed (cm\^3)
6 Month Ulcer Size (Length)
时间窗: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Width)
时间窗: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Volume)
时间窗: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters cubed (cm\^3)
Baseline Clinical Evaluation
时间窗: Start of Treatment (Baseline)
Clinical evaluation by the physician and assessment of the subject's symptoms
3 Month Clinical Evaluation; Change Assessment
时间窗: 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.
3 Month Ulcer Healing Rate Change
时间窗: 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 (%)
Baseline Ulcer Size (Length)
时间窗: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters (cm)
Baseline Ulcer Size (Width)
时间窗: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters (cm)
Baseline Ulcer Size (Surface Area)
时间窗: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters squared (cm\^2)
Baseline Ulcer Size (Volume)
时间窗: Start of Treatment (Baseline)
Measurement of the ulcer; Recorded in centimeters cubed (cm\^3)
3 Month Ulcer Size (Length)
时间窗: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Surface Area)
时间窗: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters squared (cm\^2)
6 Month Clinical Evaluation; Change Assessment
时间窗: 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 Clinical Severity Score (VCSS)
时间窗: 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.
Baseline_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym)
时间窗: 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
时间窗: 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.
3 Month Ulcer Size (Depth)
时间窗: 3 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month Ulcer Size (Depth)
时间窗: 6 months following start of treatment
Measurement of the ulcer; Recorded in centimeters (cm)
6 Month_Venous Clinical Severity Score (VCSS); Change Assessment
时间窗: 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.
6 Month_ Venous Insufficiency Epidemiological and Economic Study- Quality of Life/Symptoms (VEINES-QOL/Sym); Change Assessment
时间窗: 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.
3 Month_Venous Clinical Severity Score (VCSS); Change Assessment)
时间窗: 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.
次要结局
- Number of Days to Healed Status(From Date of Randomization until the date of documented healed status, assessed up to 365 days)
研究者
Jihad Abbas, MD
Principal Investigator, Vascular Surgeon, MD
ProMedica Health System