Evaluation of safety and efficacy of topical esmolol hydrochloride gel in treating diabetic foot ulcer: a multicenter, prospective, open-label phase 4 study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 45
- 主要终点
- Assess safety and tolerability of Esmolol Hydrochloride gel in diabetic foot ulcer subjects
研究概览
简要总结
This is a multicenter, prospective, open-label study. Type 1 or Type 2 Diabetes patients with unhealed diabetic foot ulcer for at least 6 weeks will be screened for the study. At least four hundred patients satisfying the eligibility criteria will be enrolled and treated for the next 12 weeks or until the closure of ulcer whichever is earlier. Upon confirmation of eligibility, patient will be enrolled in the study. Thereafter, twice daily application of the investigational product (Esmolol Hydrochloride Topical Gel 14% w/w) will be initiated.
The study will have a screening visit, baseline visit, treatment visits on week 1, week 2, week 4, week 6 and week 8, and end of study visit (week 12).
Safety assessment will be based on clinically significant changes in laboratory parameters and incidence of adverse events.
Efficacy will be evaluated based on proportion of subjects achieving Target Ulcer closure during treatment period till end of study and time to Target Ulcer closure during the 12 week treatment period, as assessed by the investigator. Reduction in ulcer area from baseline to end of study will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subjects with HbA1c less than or equal to 12 percent
- •Type 1 or Type 2 diabetes patient undergoing therapy for glycemic control
- •Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index greater than or equal to 0.65
- •Ulcer is uninfected or mildly infected as per IWGDF or IDSA guidelines
- •Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit
- •Ulcer is located below or up to 5cm above the malleoli excluding ulcers between the toes
- •Ulcer size is greater than or equal to 1 cm2 and less than or equal to 20 cm2 post debridement
- •There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post debridement
- •No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts
- •Ulcer area reduction less than 20 percent from the Screening Visit to Baseline visit 12.Subject is able and willing to comply with study procedures and adhere to protocol during the study in the opinion of Investigator
- •A Subject or LAR agrees to sign informed consent form.
排除标准
- •Deeply infected ulcers with exposed bone or associated with osteomyelitis
- •Subjects who are systemically well and metabolically stable but also has 1 or more ulcer characteristics of cellulitis extending more than 2cm or lymphangitic streaking, or spread beneath the superficial fascia or deep tissue abscess or gangrene in the opinion of the Investigator
- •Infection in patient with systemic toxicity or metabolic instability
- •Subjects showing inflammatory response of the skin caused by trauma, gout, acute charcot neuro-osteo arthropathy, fracture, thrombosis or venous stasis
- •Hemoglobin less than 8 gram per deciliter
- •White Blood Cells less than 2000 per microliter
- •Albumin less than 2.5 gram per deciliter
- •e-GFR less than 30 ml per min per 1.73m2 of body surface area
- •Subject has ulcers caused by a disease other than diabetes, for example fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator 10.Presence of any existing clinically significant medical conditions that, in the opinion of the Investigator, could interfere with wound healing
- •Patient diagnosed with HIV or cancer undergoing chemotherapy or using immunosuppressant drugs except inhalers for respiratory disorders and colchicine
- •Subjects who have received therapy for the treatment of diabetic foot in last 2 weeks
- •Subject with intolerance to beta blockers at any time in the past
- •Patients on another investigational agent or device or therapy or participated in a clinical trial within the last 4 weeks prior to enrollment
- •Pregnant or lactating women or women of childbearing potential not practicing contraception
- •Has any other factor which may, in the opinion of the Investigator, compromise participation or follow up in the Study.
结局指标
主要结局
Assess safety and tolerability of Esmolol Hydrochloride gel in diabetic foot ulcer subjects
时间窗: Baseline to End of Study
次要结局
- Assess efficacy of Esmolol Hydrochloride gel in diabetic foot ulcer subjects in terms of proportion of subjects achieving Target Ulcer closure within 12 week treatment period and assess the time to Target Ulcer closure within 12 week treatment period
研究者
Dr Anil Pareek
Ipca Laboratories Limited