An interventional, open label, randomized, three arm comparative, Multi centric, post market clinical study to evaluate the safety and efficacy of medical devices used in adjuvant to the treatment of Venous leg ulcer.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- 1. Complete wound closure within 60 days.
研究概览
简要总结
The cause of venous ulcers is high pressure in the veins of the lower leg. The veins have one-way valves that keep blood flowing up toward your heart. When these valves become weak or the veins become scarred and blocked, blood can flow backward and pool in your legs. This is called venous insufficiency. This leads to the high pressure in the lower leg veins. The increase in pressure and buildup of fluid prevents nutrients and oxygen from getting to tissues. The lack of nutrients causes cells to die, damaging the tissue, and a wound is form.
Venous ulcers are generally irregular, shallow, and located over bony prominences. Granulation tissue and fibrin are typically present in the ulcer base. Associated findings include lower extremity varicosities, edema, venous dermatitis, and Lipodermatosclerosis.
Wound dressings are the key components of effective venous leg ulcer treatment. medical adhesive can help the patient be more comfortable and promote rapid healing,
By comparing these treatment arms, the study seeks to identify the most effective and safe approach for VLU management. Assessing wound healing rates, infection prevention, patient comfort, and cost-effectiveness will provide valuable insights into the optimal utilization of these interventions. Hence, the findings of this study aim to improve clinical outcomes and quality of life for patients suffering from VLUs, filling critical gaps in current treatment guidelines and practice.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent from the subject/ or legally authorized representatives (LAR) who is able to read, understand informed consent, and sign the informed consent.
- •Subjects who allow their data to be collected for the study at pre-defined follow-up periods.
- •Adult non-diabetic, patients, with venous ulcers unresponsive to conventional therapy, in the age group of 18 years to 70 years.
- •(Both included)
- •Subjects with ulcers of venous origin, as clinically determined by the investigator by a positive venous reflux test using Doppler ultrasound or Ankle-brachial index, on the day of screening, which have not adequately responded to conventional ulcer therapy.
- •Ulcers that extend through the epidermis but not through muscle, tendon, or bone (Stage II or III ulcers as defined by the IAET).
- •Subjects having active Venous leg ulcer.
- •(Grade C-5 and above)
- •Active Venous Leg Ulcers with Wound area criteria post-debridement between 5 cm2 to and 40 cm2.
排除标准
- •Subjects unwilling or unable to comply with the postoperative visits necessary for data collection
- •Severe clinical infection, highly exuding wounds, active systemic infections, like pus oozing from ulcer site
- •HbA1c level of participant will Greater than and equal to 6.
- •The ulcer to be treated requires operative debridement.
- •Highly exuding wounds (wounds that require a daily dressing change).
- •Subjects with active systemic infections
- •Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer).
- •Subjects with active osteomyelitis or connective tissue disease of the affected foot.
- •Subjects found positive for HIV, HCV, and HBsAg.
- •Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
- •Comorbidities which could interfere with clinical evaluations or interpretation of results.
- •Subjects with known allergy to the constituents of investigational products/ device.
- •Subjects with Ankle-brachial pressure index (ABPI) less than and equal to 0.8.
结局指标
主要结局
1. Complete wound closure within 60 days.
时间窗: Total duration of the trial is 60 days from the first dressing application
2. Rate of wound healing, measured by percentage reduction in wound size from baseline to wound healing day or day 60 whichever is earlier.
时间窗: Total duration of the trial is 60 days from the first dressing application
3. Incidence of wound infection (Assessed by clinical evaluation and microbiological analysis by swab test) from baseline to wound healing day or day 60 whichever is earlier.
时间窗: Total duration of the trial is 60 days from the first dressing application
次要结局
- 1. Assessment of wound closure rates and pain intensity assessment using a Pain Chart, on a scale of 0-10 Numeric from baseline to wound healing day or day 60 whichever is earlier.(2. Wound showing reduction of ≥ 70% of the initial wound size by day 60.)
研究者
Dr Sudhir Kumar
HOD Plastic Surgery, MLB hospital, Jhansi