Prospective, Randomized, Investigator Initiated, Controlled Study to determine Haemostatic Efficacy of STASITM Non-Absorbable Sponge to control bleeding after debridement of Diabetic Foot Ulcers as compared to sterile gauze in patients taking Anticoagulants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This investigator-initiated, prospective, randomized, controlled study evaluates the haemostatic efficacy and safety of STASI™ Non-Absorbable Sponge versus standard sterile gauze in controlling bleeding after minor debridement of diabetic foot ulcers in patients receiving anticoagulant therapy. Conducted at Shraddha Multispecialty Hospital, Gujarat, the trial will enroll 20 adult patients randomized 1:1 into study and control arms. Haemostasis will be assessed at 5 and 10 minutes post-application, with success defined as cessation of bleeding without additional measures within 10 minutes. Follow-up on Day 7 ± 1 will evaluate adverse events, ulcer healing, rebleeding, or hematoma formation.
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
- •Adults male or female subjects aged 18 years and above with type I or II diabetes mellitus.
- •Ulcer classified as Wagner grade I or II ulcers (more than 2 cm in diameter size and less than 10cm, and a duration of more than 6 weeks).
- •Patients with good extremity circulation status, palpable pulse or confirmation with doppler sonography at the ankle (dorsalis pedis artery or posterior tibial artery).
- •Received anticoagulation therapy due to diabetic vasculopathy or systemic disease.
- •Patients with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements.
排除标准
- •Hypersensitivity to STASITM Non-Absorbable Sponge or other components.
- •Pregnant or lactating women.
- •Patients undergoing Immunosuppressant therapy or systemic cardiopulmonary disease.
- •Refusal or inability to provide consent.
研究者
Dr Rajat K Engineer
Shraddha Multispeciality Hopsital