EUCTR2015-002180-41-EE进行中（未招募）不适用
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 人开始时间: 2015年7月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 422
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •oIf more than one ulcer is present that meets the Inclusion Criteria, the largest one meeting all criteria will be considered the target ulcer.
- •oIf there are two ulcers the same size that meet all criteria the one with the higher Wagner Grade will be considered the target ulcer.
- •oIf there are two ulcers of the same size and same Wagner Grade, the one present for the longest (qualifying) time will be considered the target ulcer.
- •oNon-target ulcers will also be treated according to Standard of Care (Charcot Neuroarthropathy of the foot with the target ulcer must be excluded).
- •4.Has an ankle brachial index (ABI) >0.7 on the leg of the foot with the target ulcer.
- •5.Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments. A subject will be considered to have site-specific neuropathy sufficient for loss of protective sensation (LOPS) if he/she is unable to feel a 5.07 Semmes-Weinstein monofilament in at least five of the following seven sites on the study foot:
- •oPlantar to toes and metatarsals 1, 3, and 5 (three sites).
- •oPlantar to midfoot medial and lateral (two sites).
- •oPlantar heel (one site).
- •oDorsal distal first interspace (one site).
- •6.A female subject of childbearing potential must have a negative serum pregnancy test at the time of Screening.
- •7.A female subject of childbearing potential must be willing to use a medically acceptable method of birth control, such as Essure®, hormonal contraception (oral pills, implantable device, or skin patch), intrauterine device, tubal ligation, or double barrier throughout the study. A female subject of childbearing potential who practices abstinence is not required to employ birth control.
- •8.Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •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).
- •10.Has an ulcer primarily ischemic in etiology as diagnosed by an ABI of <0.7 on the affected extremity or great toe systolic pressure <50 mmHg or a transcutaneous oxygen pressure (TcPO2) <40 mmHg in the supine position and <40 mmHg while sitting, measured on the forefoot with electrode set at 44 C on the affected foot.
- •11.Has sickle-cell anemia, Reynaud's, or other peripheral vascular disease.
- •12. Has received a biologic agent to include growth factors and skin equivalents (Regranex®, Apligraft, or Dermagraft), in the past 30 days.
- •13.Has a target ulcer which is determined to be clinically infected and requires antimicrobials. Any antibiotic therapy must be completed or discontinued at screening.
- •14.Has a Wagner Grade 3 or greater DFU, deep abscess, or gangrene.
- •15.Has uncontrolled hypertension, in the opinion of the Investigator.
- •16.Any other finding, which in the opinion of the Investigator, may interfere with the assessment of the product or participation of the subject in the study.
研究者
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