A Randomized, Double-Blind, Parallel-group, Vehicle-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Aclerastide (DSC127) in Treating Non-healing Foot Ulcers in Subjects with Diabetes Mellitus

Derma Sciencs Inc0 个研究点目标入组 422 人2015年5月25日

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注册库

who.int

开始日期

2015年5月25日

结束日期

待定

最后更新

9年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Derma Sciencs Inc

•A subject who meets all the following criteria will be included in the study:
•1\.Male or female ambulatory subject age \=18 years at the time of informed consent.
•2\.Has type 1 or type 2 DM under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) of \=12% and a serum creatinine level of \=3mg/dL.
•3\.At Screening and at Baseline (prior to randomization), subject has at least ulcer that fulfills all of the following criteria:
•a) present for \=1 month and \= 1year.
•b)Partial\- or full\- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule), i.e., Wagner Grade 1 or 2\.
•c)Has no sign of infection or osteomyelitis
•d)Plantar neuropathic ulcer \- The ulcer must predominately be on the plantar surface (i.e., weight bearing) of the foot to ensure adequate off\-loading, and may include the toes but edges of the ulcer may be extended to the sides of the foot.
•e)Size of the target ulcer must be 0\.75 \- 6 cm.2
•f)Target ulcer must be non\-healing as defined as \<30% reduction in size in response to Standard of Care during the two\-week Screening Period.

•A subject satisfying any of the following criteria will be excluded from participating in the study:
•1\.Has a known hypersensitivity to any of the investigational drug or vehicle components.
•2\.Has been exposed to any investigational agent within 30 days of entry into the study.
•3\.A female who is pregnant or nursing.
•4\.Has active malignant disease of any kind except for basal cell carcinoma (of the skin). A subject, who has had a malignant disease in the past, was treated and is currently disease\-free, may be considered for study entry.
•5\.Has a hemoglobin of less than 8\.5 gm/dL.
•6\. Transaminase levels greater than 3x normal.
•7\.Is receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy.
•8\.Has had prior radiation therapy of any part of the foot with the target ulcer under study.
•9\.Use of systemic corticosteroids or immunosuppressants (within the 8 weeks prior to screening).