Role of addition of Stem Cells or Platelet Rich Fibrin in the healing of chronic lower extremity venous ulcers compared to Endo Venous Laser Ablation alone.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percentage reduction in ulcer size over a specific time period after additional treatment with stem cells or Platelet Rich Fibrin as compared to EVLA alone.
研究概览
简要总结
Chronic venous ulcers are a significant health burden, often leading to prolonged morbidity and reduced quality of life. Conventional treatment strategies, including compression therapy and surgical interventions, have limitations in healing time and recurrence rates. Endovenous Laser Ablation (EVLA) is an effective modality for treating underlying venous insufficiency; however, it does not directly promote ulcer healing. Recent advances in regenerative medicine have introduced autologous stem cells and platelet-rich derivatives such as PRF as promising adjuncts to enhance tissue repair. This randomized, prospective, interventional study aims to evaluate and compare the effectiveness of three treatment modalities: 1. EVLA alone (control group) 2. EVLA with perilesional injection of autologous stem cells (mesenchymal stem cells derived from bone marrow) 3. EVLA with perilesional injection of autologous platelet-rich fibrin (PRF) Patients diagnosed with chronic venous ulcers due to superficial venous insufficiency will be randomly assigned into one of the three treatment groups. The primary outcome measure will be the rate of ulcer healing, assessed by reduction in ulcer size and complete healing over a 6-month period. Secondary outcomes will include recurrence rate at 6 months and any adverse events related to the procedures. This study is expected to provide evidence regarding the utility of biologic adjuncts like stem cells and PRF in accelerating healing and improving outcomes in venous ulcer patients, potentially shaping future management protocols for chronic wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of 18 to 75 years age with chronic venous ulcer of lower limb of more than 6 weeks duration.
排除标准
- •Patients with ulcers of non-venous origin.
- •Patients with active local or systemic infection.
- •Immunocompromised patients.
- •Patients with uncontrolled diabetes mellitus.
- •Patients with severe anemia.
- •Pregnant and lactating women.
- •Patients with history of malignancy or undergoing chemotherapy or radiotherapy.
- •Patients with poor general condition or unfit for procedure as per clinical judgement.
- •Severe hypercoagulability syndromes or having DVT.
- •Patient not willing to give consent.
结局指标
主要结局
Percentage reduction in ulcer size over a specific time period after additional treatment with stem cells or Platelet Rich Fibrin as compared to EVLA alone.
时间窗: 6 months after intervention
次要结局
- Number of days/weeks required for complete closure of the venous ulcer.(Whenever the ulcer heals.)
- Incidence of ulcer recurrence within 6 months post-procedure.(6 months after intervention.)
- Any local or systemic side effects related to stem cell or Platelet Rich Fibrin therapy.(6 months after intervention)
研究者
Hamza Ansari
AIIMS, New Delhi
