ACTRN12621000120875尚未招募1 期
Blockade of mini-TrpRS for treatment of diabetic foot syndrome: A Prospective open-label phase 1a/1b randomized placebo-controlled trial.
Townsville University Hospital0 个研究点目标入组 112 人开始时间: 2021年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1.Subjects greater than or equal to 18 years of age diagnosed with type 2 diabetes on diet only or any diabetic medication regime.
- •2.Existing diabetes index foot ulcer grade A1 or higher according to the University of Texas Wound Classification System of Diabetic Foot Ulcers on the day of study inclusion. A foot ulcer is defined as any full-thickness skin defect existing for at least 14 days. In patients with multiple diabetic foot ulcers, the index foot ulcer is defined as the foot ulcer with the largest wound area at the time of inclusion
排除标准
- •Exclusion Criteria:
- •1)Type 1 Diabetes.
- •2)Current index foot ulcer of any non-diabetic pathophysiology (e.g. rheumatoid, radiation-related, vasculitis-related, calciphylaxis, or dystrophic calcinosis cutis, etc.).
- •3)Any major surgery up to 6 months before the day of enrolment or any planned surgery before study completion, including any major surgical intervention for the diabetic foot ulcer.
- •4)Significant medical conditions that potentially impair wound healing and/or alter the concentration of serum immune markers including hepatic, respiratory or cardiac failure, aplastic anemia, autoimmune diseases (e.g., Lupus erythematosus, scleroderma, etc.), chronic inflammatory diseases (e.g., inflammatory bowel disease, inflammatory or rheumatoid arthritis, etc.) and any active malignancies including cancerous or pre-cancerous lesions in the ulcer area other than basal cell carcinoma.
- •5)Any concomitant medication which could potentially alter the concentration of serum immune markers during the study including systemic cortocosteroids, immunosuppressants, chemotherapeutic agents, growths factor products, etc.
- •6)Skin and dermal substitutes within 30 days before study enrolment.
- •7)Enzymatic debridement treatment.
- •8)Active Charcot's foot as determined by clinical and radiographic examination.
- •9)Significant renal impairment (eGFR < 30 ml/min).
- •10)Pregnancy, lactation or child-bearing potential. Women must be either of non-childbearing potential as defined in the protocol or must have a negative pregnancy test on the day of study inclusion or randomization and agree to use an adequate method of contraception as defined in the protocol for at least until two weeks after taking the last dose of study medication. Also, men who take part in this study should genuinely not plan to get their partners pregnant (no active family planning) while participating in this study and until 14 days after taking the last dose of study medication.
- •11)Participation in any other clinical trial.
- •12)Inability to comply with study protocol.
- •13)Any current or new contraindication, special warning, precaution or other patient safety-related concern relevant to the patient at the time of enrolment as listed in the current product information.
研究者
相似试验
尚未招募
3 期
Evaluating safety and efficacy of zinc ang magnesium supplements in Type 2 diabetic patients along with standard care of treatamentCTRI/2024/07/071237Dr Santra Sunny (self)
招募中
不适用
A study on the analgesic effect of scrambler treatment in painful diabetic neuropathyDiseases of the nervous systemKCT0007201Ewha Womens University13
已完成
2 期
Anti-platelet therapy for prevention of diabetic nephropathydiabetic nephropathyJPRN-UMIN000007718ational Hospital Organization Headquarters150
尚未招募
Unknown
A study to assess the effect of a combination of glucose lowering medicines in prevention of type 2 diabetes among women with previous history of gestational diabetes mellitus and having pre-diabetesCTRI/2024/05/067588Indian Council of Medical Research (ICMR)
已完成
Unknown
A Novel Approach for Diabetes Intervention Using a Health Story-Telling TechniqueStorytelling as health intervention in diabeticJPRN-UMIN000049575Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 2500030