CTRI/2024/12/078006尚未招募2 期
Comparison of topical timolol versus conventional therapy for healing of chronic non-healing wounds- a randomized control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To determine the effect of topical timolol on wound healing in chronic non-healing ulcers measured in terms of percentage reduction in wound surface area over an 8 week period
研究概览
简要总结
Timolol has been used in very few studies for chronic ulcers; even those studies have used small sample sizes. Therefore, the therapeutic advantages of the medicine in chronic wounds need to be better supported by evidence. Hence, we proposed this study to determine whether topical timolol instillation, as opposed to standard wound treatment, will result in faster wound healing in chronic non-healing wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above 18 years of age with chronic ulcers of more than 4 weeks duration and less than 1 year duration
- •Surface area between 0.5 cm2 and 100 cm2 (measured using the smartphone-based app -imito measure11).
- •Ulcers with the largest surface area and longest duration meet the criteria in case of multiple ulcers.
排除标准
- •1.Pressure ulcers
- •Patients with history of bradycardia (heart rate less than 60)
- •Patients with medically documented history of hypotension/orthostatic hypotension and/or symptomatic hypotension (systolic blood pressure below 90 and diastolic blood pressure less than 60).
- •Patients currently taking asthma or COPD medications
- •Patients having palpitations, syncope, dyspnea, and/or angina at rest
- •Ulcers with signs of active infection such as cellulitis, purulent exudate, osteomyelitis or exposed bones, tendon and fascia
- •Patients with known immunodeficiency
- •Patients with known chronic kidney or liver disease
- •Patients who received prior radiation or chemotherapy
- •Female patients who are pregnant.
结局指标
主要结局
To determine the effect of topical timolol on wound healing in chronic non-healing ulcers measured in terms of percentage reduction in wound surface area over an 8 week period
时间窗: At the time of initial presentation-day 1 | At the end of 2,4,6 and 8 weeks
次要结局
- To assess the pathological strength of granulation.(Over an 8 week period)
- To assess the microbiological profile of the ulcer.(Over an 8 week period)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Efficacy and Safety of Topical Timolol in Secondary Intention Surgical Wounds HealingNCT07384767University of California, Davis220
已完成
不适用
A study to evaluate effectiveness of timolol on skin ulceration in breast carcinoma patients as a newer treatment.CTRI/2019/07/020078Bankura Sammilani Medical College and hospital
招募中
2 期
Acetic Acid in Cutaneous Ulcers. Randomized Controlled Trial.2023-504348-32-01Consorci Sanitari De L'Alt Penedes I Garraf104
尚未招募
不适用
A study to compare the efficacy of topical Tacrolimus cream and topical Tofacitinib ointment in patients with alopecia areata single patchCTRI/2025/11/097722Department of Health Research under MoHFW44
招募中
不适用
Palatal Wound Healing After Free Gingival Graft SurgeryNCT07409571Kahramanmaras Sutcu Imam University55